MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS; GUIDE

Catalog Number	03.010.497
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on (b)(6) 2018, the cam lock lever for radiolucent aiming arm was broken off upon inspection when the femoral recon nail set was opened from the packaging.There was no patient involvement.Concomitant device reported: radiolucent aiming arm (part# 03.033.003, lot# unknown, quantity# 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
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.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.
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.A manufacturing investigation was performed on the complaint device at the manufacturing site and is summarized below.Manufacturing investigation: visual inspection: the shipped device 03.033.003, ¿aim-arm radioluc f/greater trochanter fe¿ with lot number l699665 is in proper condition.No special or heavily used look.The complained component 03.010.497 ¿cam-lock lever f/aiming arm¿ which was built in is broken and was not receipt with the device.Only the rest of the article 03.010.497 ¿cam-lock lever f/aiming arms¿ is left.Functional inspection: since the component 03.010.497 has been broken off, the function test cannot be carried out.Dimensional inspection: since the component 03.010.497 has been broken off, so a dimensional inspection cannot be carried out.Dhr review: the cam lever 03.010.497, is a sub-component of part #: 03.033.003 lot # l699665 , part: 03.033.003, lot: l699665, manufacturing site: haegendorf, release to warehouse date: 22.Feb.2018.The device history record shows this lot 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.Material/hardness review: the raw material certificate was reviewed and the used raw material ¿peek-classix white¿ (charge # er7650996) was according to the specification of the device.Manufacturing summary/conclusion: the manufacturing evaluation conducted shows that there was no issue during the manufacture of the product that would contribute to this complaint condition.No manufacturing issue was found during investigation.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 the cam lever 03.010.497, is a sub-component of part #: 03.033.003 lot # l699665 , part: 03.033.003, lot: l699665, manufacturing site: haegendorf, release to warehouse date: 22.Feb.2018.The device history record shows this lot 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.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: CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7915054
• Report Number: 2939274-2018-53967
• Device Sequence Number: 857446
• Product Code: FZX
• UDI-Device Identifier: 10886982069146
• UDI-Public: (01)10886982069146
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup,Followup
• Report Date (Section B): 09/04/2018

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 Catalogue Number: 03.010.497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 11/01/2018; 01/03/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/01/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1