MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11 405 / STERILE; NAIL, FIXATION, BONE

Model Number	04.043.355S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
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.Additional pro-code: hwc.(b)(6).Initial reporter is a j&j sales representative.Part #: 04.043.355s-us.Lot #: 694p121.Manufacturing site: (b)(4).Release to warehouse date: 25, march 2022.Expiry date: 29, february 2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified the investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2022, while attempting to ream, the reaming shaft would not pass over the reaming rod.It was the determined that the flanges at the tip were bent.Another shaft was used and the surgery progressed.While drilling for a proximal interlocking screw, the drill bit hit the nail and would not pass.Another screw hole was selected and successfully placed.The surgery was successfully completed.No surgical delay.No patient consequence.This complaint involves two (2) devices.This report is for one (1) tibial nail-advanced / 11 405 / sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 11 405 / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15992396
• Report Number: 8030965-2022-11151
• Device Sequence Number: 5995609
• Product Code: JDS
• UDI-Device Identifier: 10886982298270
• UDI-Public: (01)10886982298270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 04.043.355S
• Device Catalogue Number: 04.043.355S
• Device Lot Number: 694P121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM FLEXIBLE SHAFT 620MM; UNK - DRILL BITS: TRAUMA; UNK - REAMING RODS; UNK - SCREWS: TRAUMA
• Patient Age: 27 YR
• Patient Sex: Male