MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.212S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 additional fractures occurred post-operatively and were confirmed by x-ray for a femoral neck system (fns).Revision surgery occurred on (b)(6) 2020, in which the fns implants were removed and the patient revised to a bipolar hip arthroplasty (bha).The original open reduction internal fixation (orif) surgery for femoral neck fractures using the fns system occurred (b)(6) 2020.This is report 4 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.H3, h4, h6- the complaint condition that a fracture occurred right under the fns implants could be confirmed according to the received x-ray.Product was not returned.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 history lot part: 412.212s, lot: 4l23103, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 16 april 2019, expiry date: 01 april 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 412.212, lot number: 3l92292, manufacturing site: mezzovico, release to warehouse date: 27 march 2019.A manufacturing record evaluation was performed for the non-sterile 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.
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.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 SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10250442
• Report Number: 8030965-2020-04735
• Device Sequence Number: 16315974
• Product Code: KTT
• UDI-Device Identifier: 10886982275394
• UDI-Public: (01)10886982275394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000682
• 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,Followup
• Report Date (Section B): 06/24/2020

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: 412.212S
• Device Catalogue Number: 412.212S
• Device Lot Number: 4L23103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020; 08/18/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/18/2020; 08/28/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; LOCKSCR Ø5 SELF-TAP L42 TAN; PL 2HO F/FEM NECK SYST TAN
• Outcome Attributed to Adverse Event: Required Intervention