MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15

Model Number	03.240.002
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following wash on an unknown date, several products were found to be faulty.Upon manufacturer investigation, the device was discovered to be twisted/stripped.There was no patient involvement.This report is for a cannulated stardrive screwdriver shaft/t15.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.240.002; synthes lot: 6495415; supplier lot: na; release to warehouse date: january 29, 2011.Manufactured by synthes (b)(4).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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the received images.The images were reviewed, and the complaint condition is confirmed.The drive of the cannulated star drive screwdriver shaft appears to be twisted/stripped.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection was not completed.A document/specification review was completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12970687
• Report Number: 2939274-2021-07018
• Device Sequence Number: 4416533
• Product Code: HXX
• UDI-Device Identifier: 10886982077523
• UDI-Public: (01)10886982077523
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.240.002
• Device Catalogue Number: 03.240.002
• Device Lot Number: 6495415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE HOLDING FORCEPS; CONNECTOR FOR THREADED EXTRACTION HOOKS; DRILL GUIDE F/CANNUL-ANGLED BLADE PL 3.5; HOLD-SL F/314.020 314.030 314.070 314.55; RED FORCEPS SERRATED JAW-RATCHET 144; SMALL HEXAGONAL SCRDRIVER HOLDING SLV; UNIV-CHUCK W/T-HANDLE; UNIV-CHUCK W/T-HANDLE
• Patient Sex: Unknown