MBT REV TIBIAL VIEW PLT SZ5

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4)INVESTIGATION SUMMARY: According to the information received, "This instrument was broken in half." The product was not returned to Depuy Synthes, however photos were provided for review. See Attachment damaged size 5 shim.jpeg. The photo investigation revealed that MBT REV TIBIAL VIEW PLT SZ5 had broken & cracked. Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material. Since the device was not returned, a dimensional inspection cannot be performed. The overall complaint was CONFIRMED as the observed condition of the MBT REV TIBIAL VIEW PLT SZ5 would contribute to the complained device issue. Based on the investigation findings, Potential cause attributed to Unintended use error and it has been determined that no corrective and/or preventative action is proposed. There is no indication that a design or manufacturing issue has caused the complaint condition. As part of Depuy Synthes quality process, all devices are manufactured, inspected, and released to approved specifications. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.DEVICE HISTORY LOT: There is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s). A Manufacturing Records Evaluation (MRE) was not performed.