MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

Catalog Number 292.620S

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device available for evaluation: part returned.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a cannulated cancellous screw was applied to an unknown surgery, it was then noted that a threaded tip guide wire was bent.During the procedure, the surgeon attached the guide wire in question to an unknown power tool device and switched the power tool on.Then, the guide wire has rotated eccentricity.The surgeon checked the guide wire and found that it was bent.The surgeon commented that there was a high possibility that the guide wire had been bent before the package was opened.The surgery was completed successfully although it was not reported how the surgery was finished.It was unknown if there was a surgical delay.There was no adverse consequence to the patient.Concomitant device reported: unknown power tool device (part #: unknown, lot #: unknown, quantity: 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product code: hty.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the guide wire was found bent as reported in this complaint.Description of future: shaft diameter.Specification: 1.25 mm 0/-0.07.Measured: 1.245 mm.Drawing/specification review: the manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.Summary: the complaint is confirmed as the guide wire was found bent as reported in this complaint.Unfortunately we are not able to determine the exact cause of this complaint.As the part was not sent back within the original package, multiple factors could have lead to this device condition.These factors include, but are not limited to: storage issue and/ or handling error, since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues can be made.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot: part: 292.620s.Lot: l960405.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 04.July 2018.Expiry date: 01.June 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8360140
• MDR Text Key: 137285656
• Report Number: 8030965-2019-61273
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2019

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 Catalogue Number: 292.620S
• Device Lot Number: L960405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 03/18/2019
• Supplement Dates FDA Received: 02/21/2019; 04/08/2019
• Patient Sequence Number: 1