MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25 THREADED GUIDE WIRE- SPADE POINT ON BOTH ENDS 150MM; WIRE, SURGICAL

Catalog Number 292.62

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

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot: part number: 292.62, lot number: 5l76602.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.A review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, while inserting a cannulated screw and guide wire inside the bone, the guide wire broke when passing the drill across the guide.The guide wire was left inside the distal humerus bone of the patient.The fracture was complex so the physician decided to leave the guide inside the bone.There was a twenty (20) minute surgical delay.Concomitant device reported: unknown screws: cannulated (part# unknown, lot# unknown, quantity# 1) this report is for one (1) 1.25 threaded guide wire- spade point on both ends 150mm this is report 1 of 1 for (b)(4).

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.

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.

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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 292.62, lot number: 5l76602, manufacturing site: balsthal, release to warehouse date: 20.Aug.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.D6: device is not implanted, partial device remained in patient due to breakage.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: 1.25 THREADED GUIDE WIRE- SPADE POINT ON BOTH ENDS 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9637871
• MDR Text Key: 189759592
• Report Number: 8030965-2020-00687
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Device Lot Number: 5L76602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Patient Sequence Number: 1
• Treatment: UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWS: CANNULATED
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 72