MAUDE Adverse Event Report: SYNTHES GMBH INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT; GAUGE,DEPTH

Catalog Number	03.113.025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an lcp medial distal tibia internal fixation with jig procedure, the aiming arm and insertion handle did not align with lcp holes.The surgeon was unable to use these instruments for percutaneous insertion.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown tibial plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) insertn handle f/3.5mm low bnd medial distal tib plate/right.This is report 2 of 2 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.H6: narrative functional/misalignment couldn't be verified from the received picture, as there are no visible signs which could result in such an issue.Furthermore, it seems that the connection part (orientation balls and fixation screw), where the plate will be attached, is covered with blood and body fluid.Also, it's visible on the picture that aiming arm and the insertion handel got mounted together in correct direction.Product was not returned therefore no further investigation possible.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 (information or/and material), 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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11102229
• Report Number: 8030965-2020-10084
• Device Sequence Number: 17090396
• Product Code: HTJ
• UDI-Device Identifier: 07611819403765
• UDI-Public: (01)07611819403765
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2020

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 Catalogue Number: 03.113.025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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: PERCUTANEOUS AIMING ARM R F/LCP MED DIST; UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE; PERCUTANEOUS AIMING ARM R F/LCP MED DIST; UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE