UNK RESECTION BLOCK

Description of Event or Problem

IT WAS REPORTED THAT THE SCRUB TECHS WERE HAVING ISSUES ATTACHING THE 2-PRONGED ATTACHMENT PIECE TO THE TIBIAL PIN BLOCKS BECAUSE THE HOLES SEEM TO BE MANUFACTURED SMALLER THAN PREVIOUSLY. IT HAS ALSO CREATED ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. A COUPLE OF BLOCKS HAVE BROKEN AT THAT JUNCTURE, AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.