MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.030

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was 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 during routine incoming inspection, it was observed that the trochanteric femoral nail advanced (tfna) screw was stuck together with the helical blade/ screw extractor.There was no patient involvement.This report is for one (1) helical blade/screw extractor.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.E3: reporter is a synthes employee.H3, h6: part number: 03.037.030.Lot number: l884761.Manufacturing site: haegendorf.Release to warehouse date: july 26, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the helical blade/screw extractor (p/n: 03.037.030, lot number: l884761) was received at us customer quality (cq).Visual inspection of the complaint device showed a mating device (04.038.085) stuck on the distal end.Functional test: a functional assessment was performed with the complaint device.The complaint device could not be disassembled from the returned mating device.The complaint condition can be replicated.Dimensional inspection: no dimensional inspection was performed due to device received condition.Document/specification review: current and manufactured was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the complaint device cannot be disassembled from the returned mating device.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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: HELICAL BLADE/SCREW EXTRACTOR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9977542
• MDR Text Key: 188219388
• Report Number: 2939274-2020-01926
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070463
• UDI-Public: (01)10886982070463
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.030
• Device Catalogue Number: 03.037.030
• Device Lot Number: L884761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TFNA SCREW 85MM; TFNA SCREW 85MM