MAUDE Adverse Event Report: SYNTHES GMBH SLIP SLEEVE FOR THREADED HOLDING SLEEVE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.614.036
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a spinal fusion procedure treating myelopathy, the threads of the slip sleeve did not properly engage with the threads of the unknown screw.The procedure was completed using a replacement sleeve.There was no surgical delay.There is no further information available.This report is for one (1) slip sleeve for threaded holding sleeve.This is report 1 of 2 for (b)(4).
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.H3, h4, h6- visual analysis of the returned sample revealed that outersleeve f/holding sleeve no.03.614 no visual issues were identified.The dimensional inspection was not performed for the outersleeve f/holding sleeve no.03.614 due to alleged complaint condition.The functional test was performed for the outer sleeve, hold-sl and hexagonal screwdriver shaft cross pinned all the devices were able to assemble without any issues.The observed unable to assemble condition of the components is not consistent with 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 for outersleeve f/holding sleeve no.03.614.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 history lot : part # 03.614.036.Lot # 9045630.Manufacturing site: werk hägendorf.Release to warehouse date: 23 sep 2014.A manufacturing record evaluation was performed for the finished device 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.

• Brand Name: SLIP SLEEVE FOR THREADED HOLDING SLEEVE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12420865
• Report Number: 8030965-2021-07447
• Device Sequence Number: 16955300
• Product Code: LXH
• UDI-Device Identifier: 07611819964051
• UDI-Public: (01)07611819964051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 03.614.036
• Device Lot Number: 9045630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HOLD-SL; UNK - LOCKING/SET SCREWS; HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HOLD-SL; UNK - LOCKING/SET SCREWS