MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW, FIXATION, BONE

Catalog Number 214.840

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

Patient Problem Thrombosis/Thrombus (4440)

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 code: ktt.Reporter is a j&j employee.The subject 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.

Event Description

Device report from synthes reports an event in colombia as follows: it was reported that on an unknown date there was implant failure due to plaque rupture.The material was implanted on (b)(6) 2021 and removed on (b)(6) 2022.This report is for one (1) 4.5mm cortex screw self-tapping 40mm.This is report 1 of 2 for complaint (b)(4).This complaint is related to complaint (b)(4) which addresses additional devices associated with this event.

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.H10 additional narrative: g1: postal code-6805.Product code: 214.840.Lot no: 259p791.Manufacturing site: mezzovico.Release to warehouse date: 16 july 2021.A manufacturing record evaluation was performed for the not sterile finished lot number, 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.Photos of the item was received as well under attachment.Visual analysis of the returned sample revealed there were no damage or defect with the cortscr ø4.5 self-tap l40 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 cortscr ø4.5 self-tap l40 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 cortscr ø4.5 self-tap l40 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured.Revisions were reviewed: -4.5mm cortex screw self-tapping (current and manufactured).Dimensional inspection: n/a.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 CORTEX SCREW SELF-TAPPING 40MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15945801
• MDR Text Key: 305140108
• Report Number: 8030965-2022-10840
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819004665
• UDI-Public: (01)07611819004665
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K161616
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 214.840
• Device Lot Number: 259P791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention