MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ SURFACE PREP TRAY; EXTREMITY INSTRUMENTS : INSTRUMENT CASES

Catalog Number 223600112

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.Review of a provided photograph revealed damage to the instrument brackets.The investigation could not draw any conclusions about the root cause of the damage without the device to physically examine.The investigation findings did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

I was present for rts when it was brought to my attention that the trial glenosphere within the glenoid instrument pan etchings to identify std or ecc were not legible on any of the trials within the set.After completion of the case we opened an additional glenoid instrument pan to find that the trials in additional pan were also not legible.Also when supporting global ap case i noticed that the apg instrument tray lamination was peeling.

• Brand Name: APG+ SURFACE PREP TRAY
• Type of Device: EXTREMITY INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8932133
• MDR Text Key: 155703390
• Report Number: 1818910-2019-102212
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 223600112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1