MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM; SCREWDRIVERS

Catalog Number 03.010.473

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that during a routine inspection of the devices, it was noted that the stardrive screwdriver shaft is bent at the tip.The interlock screwdriver is also bent at the tip and will not hold a screw.The wood overlay on the cannulated hexagonal screwdriver is crumbled around the metal shaft.No patient or surgical involvement was reported.This report is for one (1) interlock screwdriver.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Device history record (dhr) review: part: 03.010.473; lot: 7860746; manufacturing site: (b)(4); release to warehouse date: april 05, 2012; the device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary: service and repair evaluation: the device was initially returned at service and repair.The service and repair evaluation was noted as follows: the customer reported the device was bent at the tip and was unable to hold screws.The repair technician reported the tip was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Customer quality investigation: the following investigations were performed: damage (appearance not as expected): the returned device was visually examined and the distal tip of the main driver shaft is observed to be twisted in the direction of resistance provided during screw insertion.Additionally, the distal tip of the slider bar was observed to be slightly twisted.The nut component was returned.No new issues were identified other than the minor signs of wear that does not affect the product functionality.The complaint description agree with the complaint condition and the complaint condition was confirmed.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) and no design issues were identified.Dimensional analysis could not be performed due to post-manufacturing damage.Device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.While no definitive root cause could be determined, it is possible that the age of the device (over 6 years) and device encountered unintended forces such as excessive twisting during usage or improper alignment could have contributed to bent complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no 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.

• Brand Name: INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7597398
• MDR Text Key: 111023841
• Report Number: 2939274-2018-52495
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982068941
• UDI-Public: (01)10886982068941
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.473
• Device Lot Number: 7860746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1