MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM DRILL TIP GUIDE WIRE 200MM

Catalog Number	310.243
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2019, 2.5mm drill tip guide wire broke off during the 4.5 / 5.0 proximal femoral plate implantation.During the plate implantation surgeon placed the 2.5mm drill tip guide wire through the proximal hole of the plate and under direct vision of image intensifier it was noticed that the guide wire ruptured between the neck and the greater trochanter of the femur of the patient when attempting to rearrange it with the motor, which made a sudden movement and broke the guide wire.Per surgeon broken piece is out of reach for extraction.Per surgeon there will be no health risk to the patient.No other information provided.Concomitant device reported: unknown 4.5 / 5.0 proximal femoral plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) 2.5mm drill tip guide wire 200mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.5MM DRILL TIP GUIDE WIRE 200MM
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8848291
• Report Number: 8030965-2019-66691
• Device Sequence Number: 2768790
• Product Code: FZX
• UDI-Device Identifier: 07611819755116
• UDI-Public: (01)07611819755116
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 310.243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES; UNK - PLATES
• Outcome Attributed to Adverse Event: Required Intervention