MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER/T15; SCREWDRIVERS

Model Number	314.114
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj 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 inspection of sets, one (1) bolt cutter cutting edge was chipped, two (2) depth gauge outer sleeve falls off due to missing bearing, one (1) depth gauge has a broken tip, one (1) guide sleeve has a broken/ bent tip, one (1) cannulated stardrive twisted tip, two (2) screwdrivers has a broken tip.One (1) driving cap has a broken tip, one (1) extraction instrument was stripped insertion threads, one (1) handle with quick coupling has a broken handle, one (1) handle sleeve with unknown allegation: one (1) torque limiter and one (1) tension holder driver won't lock, and one (1) drill sleeve has an unknown allegation.There was no patient involvement.This complaint involves fifteen (15) devices.This report is for (1) cannulated stardrive screwdriver/ t15.This is report 4 of 8 (b)(4).Related product complaint: (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part number:314.114.Synthes lot number: 6527327.Supplier lot number: n/a.Release to warehouse date: 15nov2010.Expiration date: n/a.Manufactured by (b)(6).No 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.Visual inspection: the cannulated stardrive screwdriver/t15 (part #: 314.144, lot #: 6527327) was received at us cq.Upon visual inspection, it was observed that the threads of the distal tip of the complaint device were twisted.No other issues were identified.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: tip id = conforming, tip od, just proximal of threaded tip = conforming.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the complaint was confirmed for the cannulated stardrive screwdriver/t15 (part #: 314.144, lot #: 6527327) as the threads of distal tip of the complaint device were observed to be twisted.While no definitive root cause could be determined, it is possible that the excessive torque/force was used during screw insertion, resulting in the twisted tip.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H11 corrected data: h6 device codes.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: CANNULATED STARDRIVE SCREWDRIVER/T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10497230
• Report Number: 2939274-2020-03987
• Device Sequence Number: 2828218
• Product Code: HXX
• UDI-Device Identifier: 10886982188526
• UDI-Public: (01)10886982188526
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/11/2020

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 Model Number: 314.114
• Device Catalogue Number: 314.114
• Device Lot Number: 6527327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLADE/SCREW GUIDE SLEEVE.; BOLT CUTTER.; CANNULATED CRUCIFORM SCREWDRIVER.; CRUCIFORM SCREWDRIVER.; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS.; DEPTH GAUGE FOR 3.5MM CORTEX SCREWS.; DRIVING CAP/THREADED.; NAIL EXTRACTOR.