MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL HEXAGONAL SCREWDRIVER LONG; SCREWDRIVERS

Model Number 314.57

Device Problems Device-Device Incompatibility (2919); Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records 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 Description

It was reported that on (b)(6) 2019, a 2.5mm long hex screwdriver from the pelvic instrument set was stripping within multiple screws.Upon inspection of the screwdriver, it is visible that the edges of the hexagonal are rounded.There was no surgical delay.Procedure outcome is unknown.There was no patient consequence.Concomitant medical devices: unknown screws (part # unknown, lot # unknown, quantity 2).This complaint involves one (1) device.

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.H10 additional narrative: h3, h4, h6: device history lot, part: 314.570, lot: 1115585, manufacturing site: haegendorf, release to warehouse date: 30.Nov.2001.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: investigation summary complaint summary: background: it was reported that on (b)(6) 2019, a 2.5mm long hex screwdriver from the pelvic instrument set was stripping within multiple screws.Upon inspection of the screwdriver, it is visible that the edges of the hexagonal are rounded.There was no surgical delay.Procedure outcome is unknown.There was no patient consequence.Investigation flow: damage- visual appearance not as expected: device condition: visual inspection performed at customer quality (cq) observed significantly worn hex tip on the returned screw driver.Furthermore, slight twisting of tip was observed in the direction of resistance encountered during screw insertion.No further issues were identified.The given complaint condition agrees with the returned device condition and therefore the complaint was confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) were reviewed and no design issues were identified.Dimensional analysis was not performed due to post manufacturing damage.No design or manufacturing defect or deficiency was observed during the investigation.A device history review was performed for the returned instrument¿s lot number and no ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Overall complaint confirmed? yes.Conclusion: a definitive root cause could not be determined.However, it is possible that the age of the device with consistent use and possible rough handling of the device could have led to this 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: SMALL HEXAGONAL SCREWDRIVER LONG
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8414920
• MDR Text Key: 138646505
• Report Number: 2939274-2019-56934
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188984
• UDI-Public: (01)10886982188984
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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
• Device Operator: Health Professional
• Device Model Number: 314.57
• Device Catalogue Number: 314.57
• Device Lot Number: 1115585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/04/2019
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION.