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
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 or Problem Description
It was reported that on (b)(6) 2020 the patient underwent an orthopedic procedure utilizing the ulnar osteotomy system.During the procedure the compression/distraction instrument did not work as smoothly as it usually does.One of the slots where you put the inner kwires would not allow the wire to pass.The mechanism to lock the wire has been mangled or the shaft is uneven and not allowing the wire to pass.The procedure was successfully completed with a ten (10) minute surgical delay.There was no patient consequence.Concomitant device: unknown kwires (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) compression/distraction instr for ulna osteotomy system.This is report 1 of 1 for (b)(4).
Additional 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.Part 03.111.907, lot 7842285: manufacturing site: balsthal.Release to warehouse date: (b)(6) 2012.Expiry date: march 01, 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A service and repair evaluation was completed: the repair technician reported the guide wire was stuck inside device when received.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the device was received assembled with guide wire.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.During functional test, the attempt to disassemble the guide wire from the returned device failed.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 or Problem Description
Updated concomitant device reported: kwire (part 02.111.903, lot 4l12699, quantity 1).

• Brand Name: COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10928161
• Report Number: 2939274-2020-05378
• Device Sequence Number: 2127466
• Product Code: HRS
• UDI-Device Identifier: 10886982072658
• UDI-Public: 10886982072658
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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
• Operator of Device: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: K-WIRE ø2 W/DRILL TIP L150 SST 10U; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES