MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP/THREADED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.010.523

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2024

Event Type  malfunction  

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.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.A manufacturing record evaluation was performed for the finished device product code: 03.010.523-15 lot number: 5169p12 it was electronically reviewed and no non-conformances/manufacturing irregularities related to the malfunction were identified.The product was released on: 04-may-2023 manufacturing site: jabil bettlach the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 03.010.523, driving cap f/insertion handle had worn out at the threaded part and as a result unable to assemble condition can also be confirmed.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device 03.010.523, driving cap f/insertion handle would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life identified and 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 Description

Device report from colombia reports an event as follows: it was reported that on 21-february-2024, prior to starting the surgery while arranging the instruments, it was observed that the threaded part of the impactor for the insertion frame was damaged.This made it difficult to attach correctly.No further information is available.This report is for a driving cap/threaded.This is report 1 of 1 for (b)(4).

• Brand Name: DRIVING CAP/THREADED
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18874742
• MDR Text Key: 337692720
• Report Number: 8030965-2024-03463
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.523
• Device Lot Number: 5169P12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1