MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL INSERTION HANDLES; ORTHOPEDIC MANUAL SURGICAL INSTRMENT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

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.B3: unknown intraoperative date.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unk - nail insertion handles/unknown lot.Part and lot numbers are unknown; udi number is unknown.E1: initial reporter is j&j company representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 Description

It was reported during a procedure on an unknown date during nail insertion , the driving cap and nail insertion handle became damaged.Both devices are in two pieces procedure was completed successfully.Patient outcome were unknown.This report is for one unknown insertion handle for (b)(4).

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.Investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample reveled the threads of the device are damaged and a thin layer of metal starting to come off.Broken threads of mating component were also observed stuck at the device hole.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces during use (off-axis or excessive hammer blows).A dimensional inspection was unable to be performed due to post manufactured damage.The overall complaint was confirmed as the observed condition of the radiolucent insertion handle frn would have contribute to the complained device issue.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 reported 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.Dimensional inspection: n/a device history part number: 03.033.001-us lot number: 3319p82 manufacturing site: hägendorf release to warehouse date: 31-jan-2023 a manufacturing record evaluation was performed for the finished device batch 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: UNK - NAIL INSERTION HANDLES
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19086312
• MDR Text Key: 340020823
• Report Number: 8030965-2024-04823
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: TRAUMA