MAUDE Adverse Event Report: SYNTHES GMBH TI CONNECTING SCREW FOR LOCKING ATTACHMENT PLATE; PLATE,FIXATION,BONE

Catalog Number 04.120.605

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that the patient underwent an initial operation on march 3, 2021.The patient underwent a revision operation on may 31, 2021 due to a broken plate.The surgery was successfully completed and the patient was doing well.This report is for one (1) ti connecting screw for locking attachment plate.This is report 2 of 5 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.H3, h4, h6: 15-sep-2021, part # 04.120.605, lot # l049707, manufacturing site: werk grenchen, release to warehouse date: 05 aug 2016.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the connection screw f/locking attachment pl (part# 04.120.605, lot# l049707 qty# 1) was returned and received at us customer quality (cq).The investigation was performed on the images provided and on the products returned.Upon visual inspection, it is observed that the hex of the connection screw was worn, but was likely due to explantation of the device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: the following drawing(s) were reviewed (current and manufactured to): -connection screw hex -connection screw hex no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the connection screw f/locking attachment pl (part# 04.120.605, lot# l049707 qty# 1).While a definitive root cause could not be identified for the reported issue from the available information, it is likely that the damage was due to the explantation of the device.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 upon these results, 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 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: TI CONNECTING SCREW FOR LOCKING ATTACHMENT PLATE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12384557
• MDR Text Key: 268693801
• Report Number: 8030965-2021-07341
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819996403
• UDI-Public: (01)07611819996403
• Combination Product (y/n): N
• PMA/PMN Number: K083573
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.120.605
• Device Lot Number: L049707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 09/15/2021
• Patient Sequence Number: 1
• Treatment: LCP-DF 4.5/5 LE 11HO L276 TAN; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; UNK - SCREWS: DISTAL FEMUR; LCP-DF 4.5/5 LE 11HO L276 TAN; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; UNK - SCREWS: DISTAL FEMUR
• Patient Outcome(s): Required Intervention