MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CORTEX SCREW 46MM; SCREW, FIXATION, BONE

Catalog Number 414.046

Device Problem Break (1069)

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.Additional device product codes: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 11 of 12 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 414.046, lot # 9120573, manufacturing site: werk grenchen, release to warehouse date: 21 aug 2014.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 cortscr ø4.5 l46 ti was observed broken at the shaft, near of the screw head.The broken fragment was not received in the evidence provided.A dimensional inspection for the cortscr ø4.5 l46 ti was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the cortscr ø4.5 l46 ti would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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, h6: the device has been received, the investigation is in progress, 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.

• Brand Name: 4.5MM TI CORTEX SCREW 46MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15852676
• MDR Text Key: 304196485
• Report Number: 8030965-2022-10231
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819030626
• UDI-Public: (01)07611819030626
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,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: 414.046
• Device Lot Number: 9120573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANNSCR ø4 SELF-DRILL L50/16 TAN GOLD.; CANNSCR Ø4 SELF-DRILL L30/10 TAN GOLD.; 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.; LOCKSCR Ø5 SELF-TAP L80 TAN.; UNK - SCREWS: TRAUMA.
• Patient Outcome(s): Required Intervention