MAUDE Adverse Event Report: SYNTHES GMBH PEDIC-SCR-MATR Ø5 CANN L25 TAN; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 04.616.525S

Device Problem Compatibility Problem (2960)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a plif (l4) performed on (b)(6) 2022.The screw in question was attached to a screwdriver at a slanted angle.Several retries did not work out.A replacing screw was attached to the same screwdriver successfully without surgical delay.No further information is available.Concomitant device: unk - screwdrivers: shafts (part# unknown, lot# unknown, quantity 1).This complaint involves one(1) device pedic-scr-matr ø5 cann l25 tan.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: additional product code: kwq, nkb, mni, kwp.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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: h3, h6: part: 04.616.525s.Lot: 6l95938.Release to warehouse date: 18 may 2020.Manufacturing site: werk selzach.Supplier: früh verpackungstechnik.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual analysis of the returned sample revealed that the pedic-scr-matr ã¸5 cann l25 tan p/n: 04.616.525s, exhibits markings consistent with normal use.No significant damage or defects were observed on the surface of the device.A dimensional inspection was unable to be performed due to device design.A functional test to assess the unable to assemble condition was conducted.The screw in question was successfully assembled to a t20 3" stardrive screwdriver.The complaint condition was not replicated.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 pedic-scr-matr ã¸5 cann l25 tan p/n: 04.616.525s 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.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: PEDIC-SCR-MATR Ø5 CANN L25 TAN
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14776753
• MDR Text Key: 303223258
• Report Number: 8030965-2022-04234
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819366497
• UDI-Public: (01)07611819366497
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.616.525S
• Device Lot Number: 6L95938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS