MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 2.5MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	314.29
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that during sterile processing on (b)(6) 2019, the handle of a cannulated hexagonal screwdriver was found broken.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) cannulated 2.5mm hexagonal screwdriver.This is report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A review of the device history record.Device history lot : part number: 314.29.Synthes lot number: 4025890.Supplier lot number: n/a.Release to warehouse date: 01 nov 1999.Expiration date: n/a.Manufactured by synthes brandywine.No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary background: it was reported that during sterile processing on september 24, 2019, the handle of a cannulated hexagonal screwdriver was found broken.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: cannulated 2.5mm hexagonal screwdriver was received at us cq.Upon visual inspection at cq, it is observed that the handle of the device has a vertical crack.The rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is confirmed.Dimensional inspection: dimensional inspection of the relevant features cannot be performed due to post manufacturing damage.Document/specification review: no design issues were found which can contribute to this complaint condition.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.The device was observed to be having a cracked handle.Thus, the complaint is confirmed.While a definitive root cause could not be identified, it is possible that the repeated usage of the device over 20 years might have contributed to the complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 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 2.5MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9177123
• Report Number: 2939274-2019-61423
• Device Sequence Number: 2692832
• Product Code: HXX
• UDI-Device Identifier: 10886982188762
• UDI-Public: (01)10886982188762
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 314.29
• Device Catalogue Number: 314.29
• Device Lot Number: 4025890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1