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

Model Number	2128-01-025
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon was attempting to broach the femoral canal of patient indicated above.The broach got stuck in the canal, so they had to open the stem removal tray, which included a depuy slap hammer.With the use of a depuy adapter, the slap hammer was attached to the stem distractor and an attempt was made to remove the broach from the patient's canal.Unfortunately, in the process, the slap hammer and adapter was damaged beyond repair.To review.One slap hammer was damaged as well as one adapter, the case was delayed , but the surgeon understood , considering the circumstances.All broken pieces were retrieved and he apologized for the damage.There was 90 minutes surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

• Brand Name: GLO ADV SLAP HAMMER ADAPTER
• Common Device Name: EXTREMITY INSTRUMENTS : IMPACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10554502
• Report Number: 1818910-2020-20479
• Device Sequence Number: 11373947
• Product Code: FZY
• UDI-Device Identifier: 10603295088073
• UDI-Public: 10603295088073
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 09/08/2020

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 Model Number: 2128-01-025
• Device Catalogue Number: 212801025
• Device Lot Number: AG409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR