MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 SCREW GUIDE PIN D1.2X5; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number 2307-90-004

Device Problems Break (1069); Entrapment of Device (1212); Component Missing (2306); Material Twisted/Bent (2981)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/12/2020

Event Type  malfunction  

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 Description

It was reported that surgeon was on 4th screw with same guide pin.Guide pin went in and screw was seated and pin was bound.Used k.Wire driver to remove and approx 1.5 inch was missing, twisted off.Used x-ray to search, located remain but not reachable per doctor.Nothing further.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.

Event Description

Additional information stated that the device broke in two pieces, and majority were recovered.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 device code: component missing will be retracted since the missing part was located and remained in the patient through an x-ray and was not reachable per surgeon.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCREW GUIDE PIN D1.2X5
• 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: 10097389
• MDR Text Key: 192467164
• Report Number: 1818910-2020-12756
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295116530
• UDI-Public: 10603295116530
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-90-004
• Device Catalogue Number: 230790004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR