MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 413.035

Device Problem Material Deformation (2976)

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 (b)(6) 2021.The patient underwent a revision operation on (b)(6) 2021 due to a broken plate.The surgery was successfully completed and the patient was doing well.This report is for one (1) 3.5mm ti locking screw self-tapping 35mm.This is report 3 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: product code: 413.035, lot number: 78p5122, manufacturing site: grenchen, release to warehouse date: 17 december 2020, expiry date: n/a.A manufacturing record evaluation was performed for the finished device lot and the non-conformance was identified.The issue of the nr was: several parts in the lot have swarf.Visual inspection: the lockscr ø3.5 self-tap l35 tan (part# 413.035, lot# 78p5122 qty# (b)(4) ) was returned and received at us customer quality (cq).The investigation was performed on the images provided and the products returned.Upon visual inspection, it is observed that the locking screw showed signs of damage on the threads, 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) (current and manufactured to) were reviewed : -locking screw ø3.5mmxl - headed blank -locking screw 3.5*xx st hex no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the lockscr ø3.5 self-tap l35 tan (part# 413.035, lot# 78p5122 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: 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12384953
• MDR Text Key: 268705432
• Report Number: 8030965-2021-07343
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819239289
• UDI-Public: (01)07611819239289
• Combination Product (y/n): N
• PMA/PMN Number: K011815
• 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: 413.035
• Device Lot Number: 78P5122
• 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: CONNECTION SCREW F/LOCKING ATTACHMENT PL; 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; UNK - SCREWS: DISTAL FEMUR; CONNECTION SCREW F/LOCKING ATTACHMENT PL; 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; UNK - SCREWS: DISTAL FEMUR
• Patient Outcome(s): Required Intervention