MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 SLAP HAMMER M6/M10 ADAPTATOR; HIP INSTRUMENT/TRIAL

Catalog Number A6779

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dr could not get either threaded tip of slap hammer to engage in the stem - he stated they seemed too wide.Both threaded tips were inspected and did not appear to have any obvious wear or damage to the threads.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The complaint description states that the dr inserted the femoral implant by hand and impacted with definitive impactor.The stem did not seat fully.Dr requested the corail slap hammer to remove stem and rebroach the canal.2 x corail slap hammers on consignment at the mater were opened and dr could not get either threaded tip of slap hammer to engage in the stem - he stated they seemed too wide.The devices associated to the complaint were not returned for analysis.The dhr analysis performed on the two corail slap hammers did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product codes and lots combinations.The picture of the two corail slap hammers provided were reviewed by supplier and cpd.From the image it was not possible to confirm any wear and tear on the instrument.Due to lack of returned parts, it has not been possible to evaluate this complaint further and the investigation remains inconclusive.Based on the information received and the investigation performed, the root cause of the incident could not be determined.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.

• Brand Name: SLAP HAMMER M6/M10 ADAPTATOR
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6177176
• MDR Text Key: 62463388
• Report Number: 1818910-2016-33533
• Device Sequence Number: 1
• Product Code: FZY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A6779
• Device Lot Number: 5252250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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