MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM; PLATE,FIXATION,BONE

Model Number 03.111.907

Device Problems Use of Device Problem (1670); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro code: hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 during an ulnar shortening procedure on (b)(6) 2019, the unknown k-wire got stuck in the compression/distraction instrument.The surgeon had to use a pliers to pull the wire out.The guide was used again, but the surgeon could not able to put the wire through the hole where the wire had stuck before.The procedure was successfully completed with a slight surgical delay.There was no patient consequence reported.This complaint involves two (2) devices.This report is 1 of 2 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.H3, h6: part: 03.111.907.Lot: 7842285.Manufacturing site: balsthal.Release to warehouse date: april 02, 2012.Expiry date: march 01, 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The complaint is unconfirmed as we are not able to confirm the complaint description based on the received pictures.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.

• Brand Name: COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9549200
• MDR Text Key: 194115166
• Report Number: 2939274-2020-00048
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982072658
• UDI-Public: (01)10886982072658
• Combination Product (y/n): N
• PMA/PMN Number: K113364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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 Expiration Date: 03/01/2022
• Device Model Number: 03.111.907
• Device Catalogue Number: 03.111.907
• Device Lot Number: 7842285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/31/2020
• Patient Sequence Number: 1