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 Device Damaged Prior to Use (2284); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, the tip of the inter-lock screwdriver stripped at the end of screw removal.It is unknown if there was a surgical delay.Procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.D10 h3, h4, h6: a review of the device history record device history lot part: 03.010.473 lot: 9046501 manufacturing site: hägendorf release to warehouse date: (b)(6) 2014 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.H3, h6: investigation summary background: it was reported that on an unknown date, the tip of the inter-lock screwdriver stripped at the end of screw removal.It is unknown if there was a surgical delay.Procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.Service and repair evaluation: the device was initially received at the service and repair department.The customer reported the tip of the inter-lock screwdriver stripped at the end of screw removal.The repair technician reported the tip of the device is bent and damaged.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was forwarded to customer quality.The evaluation was confirmed.Investigation flow: damage visual inspection: the inter-lock screwdriver t25/3.5mm hex/224mm (p/n 03.010.473 lot 9046501) was received showing a worn driver tip from consistent use and normal wear.The driver tip, on the shaft and sliding bar, were both warped and deformed.No other issues were identified with the returned components of the device.The returned screwdriver showed potential end of life indicators of bent / warped feature and deformed for driver tips.Conclusion: after a visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.H11: d4: udi & lot number provided for reporting.D10: device 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.

• 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: 8773293
• MDR Text Key: 150674119
• Report Number: 2939274-2019-59087
• Device Sequence Number: 1
• Product Code: HXX
• 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,Followup
• Report Date: 06/11/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.473
• Device Lot Number: 9046501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 09/10/2019
• Patient Sequence Number: 1