MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STERILE; SCREW, FIXATION, BONE

Model Number	04.005.526S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2021, the patient underwent surgery with the tfna implants in question.The patient was reported to be doing well.The patient had a recent fall and experienced pain.The patient experienced difficulty walked and presented to the hospital.X-rays taken on an unknown date showed the femoral head to be broken.The surgeon decided to remove the tfna implant and proceed with replacement.On (b)(6) 2021, the patient underwent replacement surgery.The implant was removed and the patient was planned for bipolar/total hip replacement.However, infection was found in the patient and the replacement procedure did not proceed.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail-sterile.This is report 1 of 5 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j employee.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.
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: visual inspection of the photos of the device was performed.The complaint condition can't be confirmed with the information available (photo analysis).A defect was not found.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A definitive root cause can't be determined based on the given information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - a manufacturing record evaluation was performed for the finished article lot 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 36MM F/IM NAIL-STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12870485
• Report Number: 8030965-2021-09761
• Device Sequence Number: 5941899
• Product Code: HWC
• UDI-Device Identifier: 10886982085955
• UDI-Public: 10886982085955
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 04.005.526S
• Device Catalogue Number: 04.005.526S
• Device Lot Number: 7L49713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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: FEM-NECKSCR PERF L85 TAN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø10 130° L200 TIMO15; TFNA FEM NAIL Ø10 130° L200 TIMO15; TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE; TRAUMA SYRING KIT 4*1 ML 2*2 ML; TRAUMACEM V+ CEMENT KIT 10 ML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female