MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM; SCREWDRIVERS

Model Number	03.010.472
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes sales consultant.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 or Problem Description
It was reported on an unknown date, the inter-lock screwdriver is broken.The interlock mechanism does not work.There were no patient and surgical involvement.This report is for one (1) interlock-screwdriver.This is report 1 of 1 for complaint (b)(4).
Additional 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.Investigation flow: damage.Visual inspection: the inter-lock screwdriver t25/3.5 mm hex/330 mm (p/n: 03.010.472, lot #: 9163823) was returned and received at us cq.Upon visual inspection, the tip of the shaft and slider were bent and deformed.No sign of breakage was identified with the returned device.Service & repair evaluation: the customer reported the device broken.The repair technician reported the tip of the device was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture all of the current and manufactured revision of drawings were reviewed complaint confirmed? no.Investigation conclusion the complaint condition was unconfirmed for the inter-lock screwdriver t25/3.5 mm hex/330 mm (p/n: 03.010.472, lot #: 9163823).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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: 03.010.472, lot number: 9163823, manufacturing site: hägendorf, release to warehouse date: dec.09, 2014.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.

• Brand Name: INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10024906
• Report Number: 2939274-2020-02239
• Device Sequence Number: 3116412
• Product Code: HXX
• UDI-Device Identifier: 10886982068934
• UDI-Public: (01)10886982068934
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 03.010.472
• Device Catalogue Number: 03.010.472
• Device Lot Number: 9163823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM