MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS LAG SCREW 12.7MM THREAD/105MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 280.050S

Device Problem Material Deformation (2976)

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

Event Date 04/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the dhs plate did not get placed on the screw.Due to the standard dhs screw being deformed or bent during the unknown surgery.No patient consequence was reported.This report is for (1) dhs/dcs lag screw 12.7mm thread/105mm-sterile.This is report 2 of 2 for (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.Visual inspection: the dhs/dcs-scr ø12.5 l105 sst (part #: 280.050s, lot #: 65p0669) was received at us cq.Visual inspection of the complaint device showed no damage or defect.The screw did not appear bent.Functional test: a functional assessment was performed with the complaint device by assembling it with the returned lcp dhs-pl 135° 2ho l60 standbarrel sst.Both devices assembled correctly as intended.The screw could slide back and forth inside the guide as intended.Can the complaint be replicated with the returned device? no.Document/specification review: (current and manufactured) was reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the device received was not bent or deformed.Moreover the screw was able to be assembled with the returned plate.No issue was identified during the investigation.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 batch: part: 280.050s.Lot: 65p0669.Manufacturing site: balsthal.Release to warehouse date: 11.Sep 2020.A manufacturing record evaluation was performed for the finished device 280.050s lot number 65p0669, 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: DHS/DCS LAG SCREW 12.7MM THREAD/105MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12009055
• MDR Text Key: 256496391
• Report Number: 8030965-2021-04976
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055285
• UDI-Public: (01)07611819055285
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.050S
• Device Lot Number: 65P0669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/20/2021
• Patient Sequence Number: 1
• Treatment: LCP DHS-PL 135° 2HO L60 STANDBARREL SST; UNK - SCREWDRIVERS; LCP DHS-PL 135° 2HO L60 STANDBARREL SST; UNK - SCREWDRIVERS