MAUDE Adverse Event Report: SYNTHES GMBH 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.075
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2024
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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a distributor h3, h4, h6: without a lot number the device history records review could not be completed.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 depuy synthes reports an event in norway as follows: it was reported that on (b)(6) 2024 during insertion of femoral recon nailing -advanced (frna) nail, the friction locking mechanism for protection sleeve 11.5/8.5 fell off on the floor.After surgery, the jig was inspected and all 4 bolts that is holding the two friction locking mechanism were loose.If pushed in, it slides out again if the jig is facing down.There was no surgical delay.This report is for one (1) 11.5mm/8.5mm protection sleeve for recon locking this is report 3 of 3 for complaint (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.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.
Event or Problem Description
It was further reported that there was no surgical delay, other than that unsterile nurse had to pick up the ¿push to lock¿ items from the floor that fell off.These are used to lock the sleeve to recon locking mode which was not needed or planned for this patient.Patient outcome is reported as planned.This is report 3 of 4 for complaint (b)(4).

• Brand Name: 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18792369
• Report Number: 8030965-2024-02954
• Device Sequence Number: 8343637
• Product Code: FZX
• UDI-Device Identifier: 07611819765672
• UDI-Public: (01)07611819765672
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Distributor
• Initial Reporter Occupation: Physician
• 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: 03.010.075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: AIM-ARM RADIOLUC F/PIRIFORMIS FOSSA FEM; AIM-ARM RADIOLUC F/PIRIFORMIS FOSSA FEM; CAM-LOCK LEVER F/AIMING ARM; CAM-LOCK LEVER F/AIMING ARM (QTY 2)
• Patient Sex: Unknown