MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 80MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 413.380

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Date 06/05/2022

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 switzerland reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, to remove plates and screws.The devices were implanted nine months prior.The surgeon noticed a strong metallosis.This report is for a screw.This is report 1 of 4 for (b)(4).Additional impacted products are captured on related complaint (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: g1: postal code: (b)(6).Part: 413.380, lot : l975205, release to warehouse date: 12.July.2018, expiration date : na, supplier: na, manufacturing site: werk grenchen.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the lockscr ø5 self-tap l80 tan.Only was observed signs of usage and normal wear which could have been a result of implantation and explantation.A dimensional inspection was performed for the lockscr ø5 self-tap l80 tan and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the lockscr ø5 self-tap l80 tan was found to have no damage or defects.No definitive root cause could 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: verriegelungsschraube 5-xx ss hex locking screw 5-xx st hex rev.G (current and manufactured).Dimensional inspection: drawing: se_105938 rev.G.Feature: total length.Specification: measured dimension: (conforming).Device used: mitutoyo digimatic caliper.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: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 80MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15853064
• MDR Text Key: 304198858
• Report Number: 8030965-2022-10236
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819240674
• UDI-Public: (01)07611819240674
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K023941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.380
• Device Lot Number: L975205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANNSCR Ø4 SELF-DRILL L30/10 TAN GOLD.; CANNSCR Ø4 SELF-DRILL L50/16 TAN GOLD.; CORTSCR Ø4.5 L46 TI.; CORTSCR Ø4.5 L46 TI.; CORTSCR Ø4.5 SELF-TAP L30 TI.; CORTSCR Ø4.5 SELF-TAP L34 TI.; LCP 4.5/5 NARROW 11HO L206 TI.; LCP-DF 4.5/5 LE 11HO L276 TAN.; LOCKSCR Ø5 SELF-TAP L18 TAN.; LOCKSCR Ø5 SELF-TAP L30 TAN.; LOCKSCR Ø5 SELF-TAP L32 TAN.; LOCKSCR Ø5 SELF-TAP L36 TAN.; LOCKSCR Ø5 SELF-TAP L40 TAN.; LOCKSCR Ø5 SELF-TAP L80 TAN.; UNK - SCREWS: TRAUMA.
• Patient Outcome(s): Required Intervention