MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE(TM) SCREWDRIVER T15

Catalog Number 314.115

Device Problem Crack (1135)

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

Event Date 01/01/2023

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: b3: date of event is an unknown date in 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.H3, h6: part: 314.115 synthes lot: 6571037 supplier lot: n/a release to warehouse date: 28 january 2011 manufactured by: synthes jennersville no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was not returned to depuy synthes, however photos were received for review.The photo investigation revealed that the device 314.115, sddrive(tm) screwdriver t15 had cracked on the handle, broken and stripped at the tip.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device 314.115, sddrive(tm) screwdriver t15 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life identified 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 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

It was reported that following sterile processing on an unknown date, it was noticed that the screwdriver handle was cracked.There were no patient consequences/outcome.Upon manufacturer investigation, it was determined that the device had cracked on the handle, and was broken and stripped at the tip.This report is for a stardrive(tm) screwdriver t15.This is report 1 of 1 for (b)(4).

• Brand Name: STARDRIVE(TM) SCREWDRIVER T15
• 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: 18483670
• MDR Text Key: 332552375
• Report Number: 8030965-2024-00549
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188533
• UDI-Public: (01)10886982188533
• 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: 314.115
• Device Lot Number: 6571037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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