MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER SHAFT T8 55MM

Catalog Number 314.453

Device Problem Mechanical Problem (1384)

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

Event Date 01/09/2024

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.D10 therapy date: (b)(6) 2024 e1 initial reporter facility name: (b)(6).H3, h4, h6: part number: 314.453 lot number: 5547p72 manufacturing site: haegendorf release to warehouse date: 12-jun-2023 a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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 had the tip stripped.This issue can be related to the reported allegation, therefore the allegation can be confirmed.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the scrdriver shaft 2.4 short self-holding f would contribute to the complained device issue.Based on the investigation findings, 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 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.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 japan as follows: it was reported that on january 9, 2023, the patient underwent the orif for the left olecranon fracture.During plate fixation, all inserted locking screws could not be fully tightened.The number of inserted screws is unknown.Although the surgeon assembled the screwdriver shaft, the torque limiter, and the handle for tightening screws, the screws could not be fully tightened.Therefore, the surgeon tightened the screws with the same feeling as when the surgeon always did.The surgery was completed successfully within 30 minutes delay.The patient was reported as stable.This report is for one (1) stardrive screwdriver shaft t8 55mm.This is report 5 of 5 for complaint (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 55MM
• 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 19380 ; 3035526892
• MDR Report Key: 19059046
• MDR Text Key: 339606994
• Report Number: 8030965-2024-04631
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819831384
• UDI-Public: 07611819831384
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.453
• Device Lot Number: 5547P72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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
• Treatment: HANDLE F/TORQUE LIMITERS 0.4/0.8/1.2NM; TORQUE LIMITER 1.2NM W/AO/ASIF-QC; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN