MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER-HEX-SMALL Ø2.5 W/GROOVE L250; SCREWDRIVER

Catalog Number 314.240

Device Problem Crack (1135)

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

Event Date 09/24/2023

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.H10 additional narrative: e3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: a product investigation was conducted.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 handle o the scrdriver-hex-small ø2.5 w/groove l250 has cracked at the bottom section.Additionally, the distal hexagonal tip was found rounded and stripped.The overall appearance of the device exhibits normal and constant use for over 7 years, no other defects were observed.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.A dimensional inspection was not performed as it is not applicable to the complaint condition.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-hex-small ø2.5 w/groove l250 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.H3, h4, h6: device history record (dhr) review conducted: part # 314.240 lot # l061582 manufacturing site: werk hagendorf release to warehouse date : 22 sep 2016 expiration date:n/a supplier: n/a a manufacturing record evaluation was performed for the finished article lot 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 depuy synthes reports an event in australia as follows: it was reported that during inspection of loan tray at central sterile services department (cssd) it was noticed that one of the screw driver handles was cracked.The associated procedure was completed without screwdriver.There was no surgical delay.During manufacturer's investigation of the returned device it was identified that he handle o the scrdriver-hex-small ø2.5 w/groove l250 has cracked at the bottom section.Additionally, the distal hexagonal tip was found rounded and stripped.This report is for one (1) scrdriver-hex-small ø2.5 w/groove l250 this is report 1 of 1 for complaint (b)(4).

• Brand Name: SCRDRIVER-HEX-SMALL Ø2.5 W/GROOVE L250
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18322875
• MDR Text Key: 330573596
• Report Number: 8030965-2023-15674
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819019928
• UDI-Public: (01)07611819019928
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.240
• Device Lot Number: L061582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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