MAUDE Adverse Event Report: SYNTHES GMBH CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L14; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.613.514S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional 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, h4, h6 investigation summary the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the threads and head recess of the cervic-spine-scr ã¸4 dynam self-drill l14 were observed stripped.This suggests that the scres may have been overtightened during the attempt of implantation.In addition, can be observed foreign substance between the threads of the screw.A dimensional inspection for the cervic-spine-scr ã¸4 dynam was not performed due to post manufacturing damage.A functional test was unable to be performed due to the nature of its functionality.However, it is reasonable that the observed conditions during the visual inspection can be attributed to the device do not have a tight fit or advanced correctly with the mating device.As part of j&j medtech orthopedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the cervic-spine-scr ã¸4 dynam self-drill l14 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 device history lot part # 04.613.514s lot # 8l92105 manufacturing site: werk selzach logistik release to warehouse date: 23.Dec.2021 expiration date: 01.Dec.2031 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part number: 04.613.514 lot number: 537p223 manufacturing site: mezzovico release to warehouse date: 13 dec 2021 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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 or Problem Description
It was reported that this was a acdf performed on (b)(6) 2024.The surgeon had experience with cervic-spine-screw and used it during surgery as usual.However, cervic-spine-screw in question did not work as expected.Therefore, it was replaced with a longer size and the surgery was completed successfully without any surgical delay.No further information is available.

• Brand Name: CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L14
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; zona industriale 4; monument 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20567838
• Report Number: 8030965-2024-13420
• Device Sequence Number: 7459237
• Product Code: KWQ
• UDI-Device Identifier: 10705034737621
• UDI-Public: (01)10705034737621(11)211213(17)311201(10)8L92105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.613.514S
• Device Lot Number: 8L92105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown