MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM/2.0MM CRUCIFORM SCRWDRVR SHAFT, SELF-RETAINING.; SCREWDRIVERS

Catalog Number	313.993
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.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) 2018, patient underwent hardware removal procedure due to pain.During the procedure, the tip of the screwdriver shaft broke.There were fragments generated and it is unknown if they were removed easily or with difficulty.There was no medical intervention required and no unanticipated x-rays taken.There was a ten-minute surgical delay, to get another screwdriver.Patient outcome is unknown.The procedure was completed successfully.Reportedly, the manufacture of the removed hardware is unknown.Concomitant devices reported: screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) 1.5mm/2.0mm cruciform screwdriver shaft, self-retaining.(b)(4).
Additional Manufacturer Narrative
Lot number, udi, physical manufacture site, date of manufacture.Subject device has been received and is currently in the evaluation process.Corrected data: date returned to manufacturer, 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.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part number: 313.993, synthes lot number: 4437987: supplier lot number: n/a, release to warehouse date: 08-oct-2002, expiration date: n/a, manufactured by synthes (b)(4): no non-conformance reports (ncrs) were generated during production.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.A product investigation was performed.Device condition: the driver (part 313.993, lot 4437987, mfg 08-oct-2002) was received at us cq broken after being forwarded from service and repair.The complaint condition was visually confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device was returned broken.The material, and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr(s).Relevant drawing(s) was reviewed.Dimensional analysis was completed, the outer diameter of the shaft, measured and is within specification based on the relevant drawing.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed as the device (part 313.993, lot 4437987) was received broken.A device inspection, device history record review and drawing review were performed as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being over torqued).No new malfunctions were observed during the course of this investigation.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 SCRWDRVR SHAFT, SELF-RETAINING.
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7350869
• Report Number: 2939274-2018-51101
• Device Sequence Number: 784984
• Product Code: HXX
• UDI-Device Identifier: 10886982188359
• UDI-Public: (01)10886982188359(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2018

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: 313.993
• Device Lot Number: 4437987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 03/07/2018; 04/17/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/03/2018; 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 174