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

Catalog Number 314.020

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

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.Device history lot dhr not available as device is older than 20 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to the filing and archiving of specification documents which was in place till august 2014.Investigation summary background: it was reported that on (b)(6) 2019, the cracked small fragment screwdriver was handed by the instrument coordinator in the sterile processing department.They did not know when or how this part was broken.There was no patient involvement.This complaint involves one (1) device.Investigation flows: broken & visual (appearance not as expected).Visual inspection: visual inspection of the returned device performed at customer quality (cq) identified a broken handle.The handle has broken at a transverse angle at the location where it is secured to the shaft with a dowel pin.One portion of the handle remains secured to the shaft but other portion was returned loose in the bag.Also the holding sleeve component was returned.Dhr review: document/specification review: the following design drawings were reviewed during this investigation.The small hexagonal screwdriver with holding sleeve (314.02(0)) is a common reusable trauma instrument, noted in multiple system technique guides including: small fragment.In each system the driver is utilized to insert screws with 2.5mm hexagonal recesses.No product design issues or discrepancies were observed during this investigation.Material analysis: the design specified the handle to be manufactured from phenolic le grade linen material.A material certification for the handle from the time of manufacture could not be reviewed during this investigation because only top level of the device history record reviewed as sub-components are not lot tracked.Based on the age of the returned device (20+ years old) there is no indication that the handle's material properties would have contributed to it breaking.Conclusion: a definitive root cause for the handle breaking could not be determined based on the provided information.It is possible that cumulative wear and rough handling and repeated thermal sterilization cycles for over 20 years of service have contributed.This complaint is confirmed for a broken handle however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

Event Description

It was reported that on (b)(6) 2019, the cracked small fragment screwdriver was handed by the instrument coordinator in the sterile processing department.They did not know when or how this part was broken.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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: b5: updated event description provided for reporting.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

(b)(6)2019: updated event description: it was reported that on (b)(6) 2019, the cracked small fragment screwdriver and a holding sleeve was handed by the instrument coordinator in the sterile processing department.They did not know when or how this part was broken.There was no patient involvement.

• Brand Name: SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8497850
• MDR Text Key: 141587054
• Report Number: 2939274-2019-57410
• Device Sequence Number: 1
• Product Code: HXX
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 314.020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/12/2019
• Patient Sequence Number: 1