MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Model Number 292.12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: hty.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 as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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

It was reported that on (b)(6) 2019, a kirschner wire (k-wire) broke during removal surgery.There were fragment generated from the broken device and the surgeon left the remaining piece of k-wire in the body.  there was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.This complaint involves one (1) device.This report is 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.H10 additional narrative: a2: date of birth provided for reporting.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

7/3/2019: updated event description: it was reported that on (b)(6) 2019, during an unknown surgery to fix a foot, a k-wire was used for provision fixation and it broke off when it was removed.An unknown plate and screws were used together with the k-wire.It broke in two pieces, other half was left in patient¿s foot and the other half was discarded.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unk - plates: foot (part # unknown, lot # unknown, quantity 1) unk - screws: trauma (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.

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.B5: update event description and concomitant devices provided for reporting.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 W/TROCAR POINT 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8746218
• MDR Text Key: 149642580
• Report Number: 2939274-2019-58922
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 20886982180343
• UDI-Public: (01)20886982180343
• Combination Product (y/n): N
• PMA/PMN Number: PREADM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292.12
• Device Catalogue Number: 292.12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR