MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 GLENO GUIDE PIN D1.5 LG 300 MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number	2307-96-000
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
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
Resistance was felt when the surgeon was attempting to remove the glenosphere guidepin by hand.Upon successful removal of the guidepin using the trs modular drive, it was noted that the removed pin is shorter than it¿s original length.Unscrewed glenosphere to attempt to find the broken part of the bit, however, unable to locate it.Interventional imaging done and pin seen on imaging.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: review of the photo confirmed the device is broken root cause undetermined.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: GLENO GUIDE PIN D1.5 LG 300 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: 10176130
• Report Number: 1818910-2020-14180
• Device Sequence Number: 16968461
• Product Code: KWS
• UDI-Device Identifier: 10603295116608
• UDI-Public: 10603295116608
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 2307-96-000
• Device Catalogue Number: 230796000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1