MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE; SCREWDRIVERS

Model Number	313.99
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
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.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2019, after sterilization, it was noticed that the following wood handle screwdrivers had a leaking dye; one (1) cruciform screwdriver with holding sleeve, ten (10) small hexagonal screwdriver with holding sleeve, one (1) large screwdriver, one (1) cannulated hexagonal screwdriver, and five (5) star drive screwdriver.All these wood handle screwdrivers are leaking dye into the trays as they have been through countless sterilizations and been in circulation for many years.There was no patient involvement.This complaint captures (8) eight out of 18 devices, remaining devices are captured under related complaint (b)(4).This report is for one (1) cruciform screwdriver with holding sleeve.This is report 1 of 8 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.H3, h6: a product investigation was conducted.Visual inspection: the cruciform screwdriver with holding sleeve (p/n 313.99 lot unk) was received showing the phenolic le grade handle discolored and worn, consistent with repeated reprocessing cycles over the part¿s lifetime and normal wear.No evidence of leaking dye was observed on the device or handle, therefore, the reported complaint is not confirmed.The discolored handle is a potential end of life indicator for the instrument from normal wear and reprocessing over the part¿s lifetime.The sleeve subcomponent (314.43) was not returned and is missing.Document/specification review: a dhr review / mre could not be performed as the lot number is unknown.The exact manufacture date is unknown.The relevant drawings, reflecting the current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is unconfirmed for the cruciform screwdriver with holding sleeve (p/n 313.99 lot unk) as no evidence of leaking dye was observed on the device or handle.The handle was discolored and worn from normal wear and reprocessing.The sleeve subcomponent (314.43) was not returned and is missing and was likely misplaced during reprocessing/surgery/device use as it can be disassembled.During this investigation no product design or manufacturing issues were observed 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8920702
• Report Number: 2939274-2019-59974
• Device Sequence Number: 19406909
• Product Code: HXX
• UDI-Device Identifier: 10886982188328
• UDI-Public: (01)10886982188328
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/25/2019

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: 313.99
• Device Catalogue Number: 313.99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1