MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	314.468
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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 japan as follows: it was reported that before surgery on (b)(6) 2023, it was found that the sleeve was unable to be engaged with the screwdriver.Another device was used for the procedure, and the procedure was completed successfully with no delay.The patient status was reported to be stable.This report involves one holding sleeve for stardrive screwdriver shaft t8.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.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 there were no damage or defect with the hold-sl f/scr ø2.4 t8 f/scrdriver shafts, no issues or signs of malfunction were observed.A dimensional inspection was performed for the hold-sl f/scr ø2.4 t8 f/scrdriver shafts and met specifications.A functional test was unable to be performed since mating device was not returned.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 not confirmed as the observed condition of the hold-sl f/scr ø2.4 t8 f/scrdriver shafts would not 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.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: - holding sleeve ø2.4 locking screw 314_468_susa rev.H (current) / rev.F (manufactured) - collet(current) / rev.C (manufactured).Dimensional inspection: drawing: rev.D specified dimensions: outer diameter of the prong tip assembly = inner diameter of the proximal insertion hole measured dimensions: outer diameter of the prong tip assembly = (conforming) inner diameter of the proximal insertion hole (conforming) device used: mitutoyo digimatic caliper (b)(4).H4, h6 part # 314.468, synthes lot # 6551013, supplier lot # n/a, release to warehouse date: 04 jan 2011, manufactured by: synthes jennersville.No non conformance reports were generated during production.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: HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17371304
• Report Number: 8030965-2023-09089
• Device Sequence Number: 7061507
• Product Code: FZX
• UDI-Device Identifier: 07611819781351
• UDI-Public: (01)07611819781351
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 314.468
• Device Lot Number: 6551013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS
• Patient Sex: Unknown