MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP,BONE

Model Number 311.01

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales consultant.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, while at the sterile processing department the sales consultant was made aware of a handle with mini quick coupling, which does not retain screwdriver blade.The hammer head of the locking slide hammer 400 grams would not attach to the shaft.The head was discarded and the other pieces of inter-lock screwdriver t25/3.5mm hex/224mm would not properly assemble.Other pieces were discarded.There was no patient involvement.This report is for one (1) handle with mini quick coupling.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A product investigation was conducted.Visual inspection: the handle with quick coupling (p/n: 311.01, lot #: 6342305) was returned and received at us cq.Upon visual inspection, there were no issues identified with the returned components of the device.Functional test: functional test was performed at s&r evaluation.Service & repair evaluation: it was reported that on an unknown date, while at the sterile processing department the sales consultant was made aware of a small collection of depuy synthes instruments that had been deemed non-functional or broken.One (1) handle with mini quick coupling does not retain screwdriver blade.The repair technician reported the device failed to operate smooth and non-binding through the entire range of operation.Non-functional item is a 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.Dimensional inspection: the complaint relevant dimensions of the internal components are inaccessible because of the design of the device hence no dimensional inspection was performed.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed complaint is confirmed as the device received is damaged.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the handle with quick coupling (p/n: 311.01, lot #: 6342305) due to failure in operating smoothly and non-binding during the s&r evaluation.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3; h6: a device history record (dhr) review was conducted: part #: 311.01, synthes lot #: 6342305, manufacturing site: synthes brandywine, release to warehouse date: 11-mar-2010.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.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: HANDLE WITH MINI QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10621150
• MDR Text Key: 209622997
• Report Number: 2939274-2020-04459
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: (01)10886982187192
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.01
• Device Catalogue Number: 311.01
• Device Lot Number: 6342305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1