MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT; GAUGE, DEPTH

Model Number	03.113.025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
It was reported that on an unknown date, during a procedure, the aiming arm for the locking compression (lcp) low bend medial distal tibia plate was not lining up with the plate properly.There was no surgical delay reported.The procedure was successfully completed.This report is for one (1) insertn handle f/3.5mm low bnd medial distal tib plate/right.This is report 1 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.The customer retaining the product.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: INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11610360
• Report Number: 2939274-2021-01669
• Device Sequence Number: 14268436
• Product Code: HTJ
• UDI-Device Identifier: 10886982072917
• UDI-Public: (01)10886982072917
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Model Number: 03.113.025
• Device Catalogue Number: 03.113.025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: A ARM 3.5 LCP LOW BND MED DSTL TIB PL/RT; UNK - PLATES: LCP MEDIAL DISTAL TIBIAL PLATE