MAUDE Adverse Event Report: SYNTHES GMBH 1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; PLATE,FIXATION,BONE

Catalog Number 04.130.110S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: additional product code : hwc.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021, the patient underwent the open reduction internal fixation.During the surgery, when the surgeon tried to insert the screw with the screwdriver shaft, the screwdriver shaft and the screw head did not match each other, and the surgeon couldn¿t insert the screw.There was no delay reported.It was unknown if the surgery completed successfully.The patient condition was stable.No further information is available.This complaint involves two (2) devices.This report is for (1) 1.3mm ti lckng screw slf-tpng with t4 stardrive recess 10mm.This report is 1 of 2 pc (b)(4).

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: h3, h4, h6- visual analysis of the returned sample revealed that lockscr ø1.3 self-tap l10 tan the hex of the screw was deformed.No other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The functional test cannot be performed as the device received by itself.However the alleged unable to assemble to condition can be confirmed since the hex was deformed might be the reason the surgeon was not able to insert the screw.The observed condition of lockscr ø1.3 self-tap l10 tan of the device was consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for lockscr ø1.3 self-tap l10 tan.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 : part: 04.130.110s.Lot: 9847024.Manufacturing site: grenchen.Release to warehouse date: 11 march 2016.Expiry date: 01 march.2026.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: 1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11642793
• MDR Text Key: 245620053
• Report Number: 8030965-2021-02763
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07612334094490
• UDI-Public: (01)07612334094490
• Combination Product (y/n): N
• PMA/PMN Number: K150099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.130.110S
• Device Lot Number: 9847024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS