MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC; SCREWDRIVER

Catalog Number 03.133.175

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure on (b)(6) 2023, a driver was not functioning properly.Procedure was completed with no delay.There were no patient outcomes or consequences reported.Upon manufacturer investigation of the device, it was determined that the tip of the driver was observed worn and stripped.This report is for a 2.5mm hex driver shaft self-retaining l 100mm qc.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a synthes employee.H3, h6: part: 03.133.175 synthes lot: j009010 supplier lot: j009010 release to warehouse date: 07 october 2022 supplier: paragon medical no nonconformance reports (ncrs) were generated during production.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection from the received image(s).Visual analysis of the photo revealed that the device is worn and stripped from the tip.A functional test was unable to be performed since the device was not returned, however, the reported issue of not functioning properly is most likely due to the damage observed on the tip.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.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 the tip of the 2.5 hex drvr sft self-retaining l 100 qc was observed worn and stripped.The reported issue of does not function is most likely due to the damage observed on the tip.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.The device exhibits damage consistent with repeated use.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed worn/stripped conditions of 2.5 hex drvr sft self-retaining l 100 qc would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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: -scrdrivershaft-hex self-retain 2.5 l100 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: 2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC
• Type of Device: SCREWDRIVER
• 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: 17669869
• MDR Text Key: 322488168
• Report Number: 8030965-2023-11087
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982269874
• UDI-Public: (01)10886982269874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.133.175
• Device Lot Number: J009010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1