MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE

Model Number	312.01
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 or Problem Description
It was reported on an unknown date, while inspecting the instruments after going through the decontamination process, it was noticed that an adjustable parallel guide wire had a missing secondary guide.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: h3, h4, h6- service & repair evaluation.The customer reported that the secondary guide of the adjustable parallel guide is missing.The repair technician reported that the device has missing components.Missing components is the reason for repair.The cause of the issue is unknown.The item was not repairable per the inspection sheet, failed synthes final inspection and will be returned to the customer quality upon completion of the service and repair process.The evaluation was confirmed.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of missing components, which agrees with the reported complaint condition.The adjustable guide sleeve component and the locking nut component and the pin component which secures the nut to the guide sleeve are missing and were not returned.Dhr review: the returned device was manufactured in june 2011 and is over 7 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Document/specification review: the 2.8mm adjustable parallel wire guide (312.01) is a reusable instrument used in the 6.5mm and 7.3mm cannulated screws system and universal locking trochanter stabilization plate system to aid in insertion of parallel 2.8mm guide wires.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: a dimensional inspection relevant to this complaint condition is not possible because of the missing components.Investigation conclusion: a definitive assignable root cause for the missing components could not be determined based on the provided information.The design is not intended to be disassembled as the pin is pressed into the nut to secure the nut and adjustable guide sleeve to the block assembly.However, the most likely cause for the complaint is forced disassembly for sterile processing and misplacing the components.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot, part number: 312.01, synthes lot number: 6688227, supplier lot number: n/a, release to warehouse date: (b)(6)2011, expiration date: n/a, manufactured by synthes jennersville.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Additional data-d10.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: 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8414949
• Report Number: 2939274-2019-56936
• Device Sequence Number: 16686895
• Product Code: FZX
• UDI-Device Identifier: 10886982187543
• UDI-Public: (01)10886982187543
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 312.01
• Device Catalogue Number: 312.01
• Device Lot Number: 6688227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1