MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.532S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, 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
Device report from synthes reports an event in (b)(6) as follows: it was reported in (b)(6) 2017, the patient underwent the surgery by using a competitors femoral implant system in order to prevent bone fractures due to the breast cancer being spread to the femur.On (b)(6) 2020, a revision surgery was performed to replace the femoral implants due to device breakage with synthes trochanteric fixation nail antirotation (tfna) long implants.On (b)(6) 2020, a revision surgery was performed due to the breakage of the tfna long implants.The patient was revised to another set of implants.There was a one (1) hour surgical delay due to extended time in removing the broken device.It was further reported the patient also had a non-union which may have contributed to the device breakage.This is report 2 of 5 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.Investigation summary: investigation site: customer quality (cq) zuchwil, selected flow: adverse event (no reported product problem).Visual inspection: the visual inspection has shown that the device is in a used condition, there are different wear marks visible.At all visible damages is the anodized layer worn away, which indicates that they were caused post-manufacturing.Investigation conclusion: the locking screw was returned as a concomitant device without an alleged complaint condition.Upon visual inspection, there is no evidence that this device contributed to the complaint condition, neither the breakage not the non-union.The visible wear marks can be traced back to the insertion, the time in-situ and extraction.There is no indication that they had any influence on the functionality of the device and therefore the complaint is rated as unconfirmed for this device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 04.005.532, lot: 4l17963, manufacturing site: mezzovico, release to warehouse date: april 10, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10343578
• Report Number: 8030965-2020-05431
• Device Sequence Number: 803776
• Product Code: HWC
• UDI-Device Identifier: 10886982086013
• UDI-Public: (01)10886982086013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.532S
• Device Catalogue Number: 04.005.532
• Device Lot Number: 4L17963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 LE 125° L340 TIMO15; TFNA HELICAL BLADE L80 TAN; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 LE 125° L340 TIMO15; TFNA HELICAL BLADE L80 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 52