MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L36 SST; PLATE, FIXATION, BONE

Catalog Number 212.212

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

Patient Problems Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported on an unknown date that the material was implanted, where there was implant failure due to plaque rupture.The material was implanted on december 1, 2021 and removed on (b)(6) 2022.This report is for one (1)lockscr ø5 self-tap l36 sst.This is report 16 of 16 for 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product codes: hwc and ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.

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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Product code: 212.212, lot number: 232p832, manufacturing site: mezzovico, release to warehouse date: 28 jun 2021.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 there were no damage or defect with the lockscr ø5 self-tap l36 sst.Only was observed signs of usage and normal wear which could have been a result of implantation and explantation.A dimensional inspection was not performed for the lockscr ø5 self-tap l36 sst since it was not applicable to the complaint condition 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 l36 sst 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKSCR Ø5 SELF-TAP L36 SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15032734
• MDR Text Key: 296009503
• Report Number: 8030965-2022-04904
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819124783
• UDI-Public: (01)07611819124783
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 212.212
• Device Lot Number: 232P832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5 VACRVD CONDY PL/12H/266/LT; 4.5 VACRVD CONDY PL/12H/266/LT; 5.0 CANNULATED VA LCK SCRW/75; 5.0 CANNULATED VA LCK SCRW/75; 5.0 CANNULATED VA LCK SCRW/85; 5.0 CANNULATED VA LCK SCRW/85; 5.0 CANNULATED VA LCK SCRW/85; 5.0 CANNULATED VA LCK SCRW/85; CANN-LOCKSCR Ø5 L60 SST; CANN-LOCKSCR Ø5 L60 SST; CANN-LOCKSCR Ø5 L80 SST; CANN-LOCKSCR Ø5 L80 SST; CANN-LOCKSCR Ø5 L80 SST; CANN-LOCKSCR Ø5 L80 SST; CANN-LOCKSCR Ø5 L85 SST; CANN-LOCKSCR Ø5 L85 SST; CANN-LOCKSCR Ø5 L85 SST; CANN-LOCKSCR Ø5 L85 SST; COMBINATION-CLAMP CLIP-ON SELF-HOLD TAV; COMBINATION-CLAMP CLIP-ON SELF-HOLD TAV; CORTSCR ø4.5 SELF-TAP L40 SST; CORTSCR ø4.5 SELF-TAP L40 SST; CORTSCR Ø4.5 SELF-TAP L38 SST; CORTSCR Ø4.5 SELF-TAP L38 SST; CORTSCR Ø4.5 SELF-TAP L44 SST; CORTSCR Ø4.5 SELF-TAP L44 SST
• Patient Outcome(s): Required Intervention