MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLO ADV SLAP HAMMER ADAPTER; EXTREMITY INSTRUMENTS : IMPACTION INSTRUMENTS

Catalog Number	212801025
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
Event or Problem Description
It was reported that the female threading stripped.Damaged male threading during use.It was indicated by the sales rep that no pieces came off the threading and no pieces were in the patient.Threads are shearing off.No surgical delay.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy synthese 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.Device history lot : null.Device history batch : null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLO ADV SLAP HAMMER ADAPTER
• Common Device Name: EXTREMITY INSTRUMENTS : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8455299
• Report Number: 1818910-2019-88582
• Device Sequence Number: 19597465
• Product Code: FZY
• UDI-Device Identifier: 10603295088073
• UDI-Public: 10603295088073
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 212801025
• Device Lot Number: AG0311
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR