MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV; SCREWDRIVERS

Catalog Number	314.67.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 discovered that the screwdriver blade with holding sleeve was broken.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is 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.H3, h4, h6: a review of the device history record device history lot part number: 314.67.96, synthes lot number: a4he861, supplier lot number: n/a, release to warehouse date: 11mar1998, expiration date: n/a, manufactured by synthes brandywine.No ncrs were generated during production.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.H3, h6: investigation summary event description: 06/18/2019: updated event description: it was reported that on an unknown date, during routine incoming inspection, it was observed that the screwdriver blade with holding sleeve was broken, fell apart and is missing components.There was no known patient or hospital involvement.This complaint involves one (1) device.Flow: damage.Visual inspection: it was noticed that distal prongs of the holding sleeve were bent and more spread out than usual.Additionally, the device was missing a blade (sub-component).Hence, the complaint is confirmed dimensional inspection: dimensional inspection of the prongs was not conducted due to the post manufacturing deformation.Document/ specification review: 314.67_2 revision c.314.67 revision j.Review of the manufacturing evaluation records showed that there were no issues during the manufacture of the product, including material, that would contribute to this complaint condition.Summary: no definitive root cause could be determined however, for the bent condition, it is likely that the device experienced excessive force during use.For the missing component, while no definitive root cause could be determined it is possible that the device being dropped during usage or handling or any unintended misplacement of components during sterilization cycles could have contributed to this missing component complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8750341
• Report Number: 2939274-2019-58948
• Device Sequence Number: 1690378
• Product Code: HXX
• UDI-Device Identifier: 10886982188991
• UDI-Public: (01)10886982188991
• 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
• 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: 314.67.96
• Device Lot Number: A4HE861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• 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: 07/29/2019
• Patient Sequence Number: 1