inforMED
MalfunctionHJT

DLC DEPTH GAUGE

Received Sep 19, 2018 · Event occurred Aug 6, 2018

Report 1818910-2018-69767 · MDR key 7889444

Device

Generic name

Hip Instruments : Drill Guides

Catalog number

227436000

Lot number

AG2018471

Product problems

  • Defective Device
  • Defective Device

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEPUY ORTHOPAEDICS, INC. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

SPRING ON DEPTH GAUGE DEFECTIVE. NO DELAY. NO PATIENT HARM. PATIENT CONSEQUENCE? :NO.