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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 195811160
• Report Number: 1818910-2020-14180
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295116608
• UDI-Public: 10603295116608
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2307-96-000
• Device Catalogue Number: 230796000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1