MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T4/66MM; SCREWDRIVERS

Catalog Number	03.114.010
Medical Device Problem Codes	Bent (1059); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Device is an instrument and is not implanted/explanted.Dhr review was completed.Mfg site: universal punch corp item: 03.114.010; lot: 7413800, mfg date: 09 oct 2018, mfg qty: (b)(4).Dhr review indicated product is manufactured by universal punch corp.With inspections and packaging occurring at the monument facility.Inspection sheet for incoming and final inspection, indicates product passed all inspection features.Certificate of conformance from universal punch corp certifies that product passed certification requirements per drawing.Raw material type "custom 465, 1875" cold worked min 60% cold reduced, hardness specification min.48, actual hardness value 54.14.Carpenter heat treat 315590.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Flow : visual.Device condition: the driver (part 03.114.010, lot 7413800, mfg 09-oct-2018) was received at us cq with a stripped distal tip.Upon visual inspection, it was noted that the distal tip is twisted and rounded.The complaint condition was visually confirmed and consistent with the reported condition.A dimensional analysis could not be completed as there is significant post manufacturing deformation present.Document/ specification review: the drawings were reviewed; no design or manufacturing defect or deficiency was observed during the investigation.Conclusion: the complaint condition is confirmed as the driver was returned stripped.The investigation flow for visual was followed to complete this investigation.While no definitive root cause could be determined, it is likely that the device was over torqued while inserting or removing a screw.The shaft is made from custom 465 stainless steel and heat treated.By design, custom 465 stainless steel is less brittle than other stainless steels and encourages the device to plastically deform/twist rather than shatter into pieces when excessive torsional forces are encountered.Twisting is a safer failure mode for the patient and user instead of having a brittle non-implant grade material shatter into fragments near the surgical site.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no further 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 or Problem Description
It was reported the stardrive screwdriver shaft was noted to be bent prior to the start of a surgical procedure.The device was removed from the set, no patient or surgical involvement.The results of the investigation of the returned device revealed the distal tip is twisted and rounded.This report is for one (1) stardrive screwdriver shaft.This is report 1 of 1 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7540384
• Report Number: 2939274-2018-52296
• Device Sequence Number: 1899145
• Product Code: HXX
• UDI-Device Identifier: 10886982073044
• UDI-Public: (01)10886982073044
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 03/26/2018

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: 03.114.010
• Device Lot Number: 7413200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1