MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T8 105MM

Model Number 314.467

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that on an unknown date, during inspection it was discovered that the instruments had issues.The aluminum hohmann retractors 24mm width, 35mm width, aluminum hohmann retractors 8 sht had pitting and scrapes.There was pitting of the stardrive screwdriver near the end of the shaft.There was no patient involvement.This report involves one (1) stardrive screwdriver shaft t8 105mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Reporter is a synthes employee.Part # 314.467, synthes lot # h416213, supplier lot # n/a, release to warehouse date: november 9, 2017, manufacturing location:(b)(4), no ncr's 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 sddrive screwdriver shaft t8 105mm (p/n: 314.467, lot number: h416213) was received at us customer quality (cq).Upon visual inspection of the complaint device and the photos, it was observed the distal tip of the complaint device was stripped and the shaft was rusted at the laser etched area.No other issues were identified for the complaint device.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: shaft diameter measured dimensions: shaft diameter =conforming device used - hand micrometer document/specification review: based on the date of manufacture, the current and manufactured revisions of the following drawing were reviewed current and manufactured revisions no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed as the distal tip of the complaint device was stripped and corrosion observed from the images provided.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.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.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12394054
• MDR Text Key: 280471931
• Report Number: 2939274-2021-05077
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188922
• UDI-Public: (01)10886982188922
• 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
• Type of Report: Initial
• Report Date: 07/12/2021

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
• Device Operator: Health Professional
• Device Model Number: 314.467
• Device Catalogue Number: 314.467
• Device Lot Number: H416213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1