MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM KIRSCHNER WIRE WITH TROCAR TIP/80MM; SCREW, FIXATION, BONE

Catalog Number 02.111.304.01

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

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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, during the procedure, the k-wire was broken.One-half of the device was in the bone.There was a surgical delay of thirty minutes.This report is for one (1) 1.25mm kirschner wire with trocar tip/80mm.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.Investigation site: cq zuchwil, selected flow: damage.Visual inspection the received k-wire was found broken in two pieces as reported.Furthermore, one broken part is bent at it's end.There are clearly visible stress marks at the surface.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: as no lot number information was made available, the actual drawing was taken for dimensional inspection.Document/specification review: the investigation has shown that no lot number was provided/ identified, therefore review for manufacturing documents is not possible.Summary: the received condition of the k-wire is concordant with the complaint description and the complaint condition is confirmed.However, based on the findings above a a manufacturing related issue can be excluded.We assume that this k-wire was exposed to very high forces during use which finally caused the breakage.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 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 KIRSCHNER WIRE WITH TROCAR TIP/80MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9981424
• MDR Text Key: 189469619
• Report Number: 8030965-2020-02965
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819419186
• UDI-Public: (01)07611819419186
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.111.304.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 06/24/2020
• Patient Sequence Number: 1