MAUDE Adverse Event Report: SYNTHES GMBH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; BONE PLATE

Catalog Number 04.503.104.04S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the surgery with the screw in question.During the surgery, one screw was stuck in the white box where four screws were set and could not be pulled out.Another screw (04.503.103.01s) was substituted.The surgery was completed successfully without any surgical delay.No further information is available.This complaint involves one (1) device matneu scr ø1.5 self-drill l4 tan 4u i/c.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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 narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.

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: e1: initial reporter address.D9, g3: device returned on 20-jul-2022.G6: follow up #1.H2, h3, h6: device evaluated.Part # 04.503.104.04s.Lot # 388p572.Manufacturing site: bettlach.Release to warehouse date: 22 september 2021.Expiry date: 01 september 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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 the matneu scr ø1.5 self-drill l4 tan 4u i/c had the edges of the threads screw with dents and worn, the distal tip was noted damaged and the shaft bent, these conditions mostly can be caused by usage / attempted, hard bone or misalignment of the screw during the procedure and cannot be traced to a manufacturing issue.A dimensional inspection for the matneu scr ø1.5 self-drill l4 tan 4u i/c was unable to be performed due to post manufacturing damage.A functional test was unable to be performed since the functionality of the screw cannot be tested with tools.The complaint condition was not able to be replicated.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 matneu scr ø1.5 self-drill l4 tan 4u i/c 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.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: MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14744239
• MDR Text Key: 302063393
• Report Number: 8030965-2022-04156
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819901643
• UDI-Public: (01)07611819901643
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.104.04S
• Device Lot Number: 388P572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1