MAUDE Adverse Event Report: SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

Catalog Number 03.019.025

Device Problem Device Slipped (1584)

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

Event Date 03/10/2023

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.E3: reporter is a j&j employee.H3, h4, h6: 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 scrdriver f/multiloc scr ø4.5 w/selfhold was found the base of device broken.The loose fragment can be confirmed.A dimensional inspection for the scrdriver f/multiloc scr ø4.5 w/selfhold was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 condition of the scrdriver f/multiloc scr ø4.5 w/selfhold would 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.Device history lot part number: 03.019.025 lot number: 539p607 manufacturing site: haegendorf release to warehouse date: 01.03.2022 a manufacturing record evaluation was performed for the finished device lot 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.

Event Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2023, the head of the inner part of the screwdriver for multilock screws felt off.There was no surgical delay, and no patient involvement.Upon visual inspection of the returned device, it was found that the base of the device was broken.This report involves one scrwdrvr f/4.5mm ti multiloc screws/slf-retain/330mm.This is report 1 of 1 for (b)(4).

• Brand Name: SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17039313
• MDR Text Key: 316334069
• Report Number: 8030965-2023-06938
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819427259
• UDI-Public: (01)07611819427259
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.025
• Device Lot Number: 539P607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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