MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 PROX REAMING GUIDE DIA 14 MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number	230774014
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 after properly assembling the reaming guide to the guide handle, surgeon inserted guide into humerus and when he tried to unscrew the reaming guide rod, the knob on the guide rod broke off leaving rod stuck in guide handle.It is unable to release the reaming guide from it.Surgeon attempted to bend tip of guide rod to free the reaming guide but was unsuccessful.Surgical delayed 5 minutes.All pieces retrieved.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Update december 5, 2018: examination of the returned device confirmed reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: PROX REAMING GUIDE DIA 14 MM
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7772391
• Report Number: 1818910-2018-66322
• Device Sequence Number: 11015890
• Product Code: LXH
• UDI-Device Identifier: 10603295116172
• UDI-Public: 10603295116172
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 230774014
• Device Lot Number: 2585729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1