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

Catalog Number	314.67.97
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative.The device was 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 that on an unknown date, during routine incoming inspection, it was observed that screwdriver shaft with holding sleeve was not mating.There was no known patient or hospital involvement.This is report 1 of 1 for (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.The short cruciform screwdriver blade with sleeve was received at the us cq.The device was received disassembled, with the external sleeve separated from the blade, inner sleeve, and internal sleeve subcomponents.The device could be reassembled with some difficulty.No other issues could be identified with the returned portions of the device.A functional test was performed on the short cruciform screwdriver blade with sleeve.The blade, inner sleeve, and internal sleeve subcomponents were already assembled.The blade was removed from this assembly, and all the subcomponents, including the external sleeve, were reassembled following the instructions.The sleeves were able to assemble without issue.The blade was able to be inserted with some force.The assembled device was able to function as intended.A dimensional inspection was not performed due to the complaint not being replicated.The received device (part # 314.67.97 lot # 4749147) was manufactured at the synthes brandywine site on 03 may 2004.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.The complaint was not confirmed for the short cruciform screwdriver blade with sleeve.The device was received with the external sleeve subcomponent not attached to the main assembly, but the device was able to be reassembled without issue following the instructions.The device subcomponents were able to mate with each other.The screwdriver was designed to assemble and disassemble by hand, and no damage or deformities could be identified.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could be determined.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: 314.67.97, synthes lot number: 4749147, supplier lot number: n/a, release to warehouse date: 03may2004, expiration date: n/a, manufactured by synthes brandywine.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.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 SHAFT 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: 8749320
• Report Number: 2939274-2019-58938
• Device Sequence Number: 2398258
• Product Code: HXX
• UDI-Device Identifier: 10886982189004
• UDI-Public: (01)10886982189004
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/04/2019

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 Catalogue Number: 314.67.97
• Device Lot Number: 4749147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1