MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; WIRE, SURGICAL

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown k-wire/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales consultant.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 Description

Device report from synthes (b)(6) reports an event as follows: it was reported that during fixation of a medial malleolus fracture on (b)(6) 2018, the kirschner wire (k-wire) snapped off in the patient while the surgeon was inserting an unknown cannulated screw.The snapped k-wire as not able to be removed.The procedure was successfully completed and there have not been any post-operative complications reported.It is unknown if there was a surgical delay.Concomitant device reported: 4.0mm cannulated screw (part/lot unknown, quantity unknown).This report is for a k-wire.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8178901
• MDR Text Key: 130822271
• Report Number: 8030965-2018-59160
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR