MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS; SCREW,FIXATION,BONE

Model Number	04.005.534
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for removal of broken pfna.The pfna was completely removed from the patient.The pfna had been in situ for over a year.This was already a revision pfna and had been used with augment.None of the hcp¿s present had a complaint about the implant failing.It was unknown if the removal surgery completed successfully.The patient outcome was unknown.Concomitant devices reported: unknown pfna helical blade (part# unknown, lot# unknown, quantity 1), unknown locking screw (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 5.0mm ti locking screw w/t25 stardrive 44mm for im nails.This report is 1 of 1 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.H10 additional narrative: updated data: h4.Investigation summary: visual inspection: the 5.0 ti lckng scr t25 sd 44 for im nails (p/n: 04.005.534, lot number: 3l11590) was received at us cq.Visual inspection of the complaint device showed the screw had broken partway down the shaft.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the screw had broken partway down the shaft.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: product code 04.005.534, lot#: 3l11590, manufacturing site: bettlach, release to warehouse date:17.April 2018.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.Corrected data: d9, g1, h3, h6.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11494677
• Report Number: 8030965-2021-02005
• Device Sequence Number: 19957768
• Product Code: HWC
• UDI-Device Identifier: 10886982086020
• UDI-Public: (01)10886982086020
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.005.534
• Device Catalogue Number: 04.005.534
• Device Lot Number: 3L11590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 L44 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L54 F/NAILS TAN LIGHT GREEN; PFNA Ø14 LONG R 130° L420 TAN; UNK - NAIL HEAD ELEMENTS: PFNA BLADE
• Outcome Attributed to Adverse Event: Required Intervention