MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER; SCREWDRIVERS

Catalog Number	313.96.96
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 313.96.96; synthes lot: a4hj291; supplier lot: na; release to warehouse date: april 28, 1998; manufactured by synthes (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the cruciform screwdriver was received at us customer quality (cq) with minimal signs of wear.However, at the very distal tip of the device, some stripping can be seen.This is consistent with the reported complaint condition, thus confirming the complaint.Conclusion: after a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing over the 20+ year lifetime of the device; therefore, further investigation for the reported complaint device is not required.It is likely that the stripped distal tip contributed to the complaint.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 during open reduction internal fixation of a hand fracture on an unknown date, one (1) holding sleeve for screws and one (1) cruciform screwdriver had an unknown malfunction.Another device set was used to complete the procedure.There was no surgical delay.Patient outcome was normal.Upon manufacturer receipt and investigation, it was determined that the tip of the cruciform screwdriver was stripped.This report is for a cruciform screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8901131
• Report Number: 2939274-2019-59854
• Device Sequence Number: 13965182
• Product Code: HXX
• UDI-Device Identifier: 10886982188274
• UDI-Public: (01)10886982188274
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 313.96.96
• Device Lot Number: A4HJ291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1