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

Model Number	314.114
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 314.114, lot 6958716: release to warehouse date: june 20, 2012.Manufactured by synthes (b)(4).No non-conformance reports (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.A product investigation was completed: upon visual inspection, it was observed that the distal tip (drive feature) of the device was twisted.No bent condition was observed on the device.Due to the twisted condition of the tip, device functionality was compromised.The noted issues were consistent as end-of-life indicators for the device.The overall complaint was confirmed for the received device as the distal tip was twisted.The reported bent condition cannot be confirmed as no deformed/bent condition was observed on the device.After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing.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 on (b)(6) 2021, it was found out that the tips of the two cannulated stardrive screwdriver t15 screwdrivers were bent.No patient consequence.Patient outcome was good.Upon visual inspection of the returned device, it was observed that the distal tip (drive feature) of the device was twisted, not bent.This is report 1 of 2 for (b)(4).

• Brand Name: CANNULATED SDDRIVE 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: 11688584
• Report Number: 2939274-2021-01936
• Device Sequence Number: 3015593
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 6958716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65