MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no patient involvement.It is unknown when device broke.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review 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 that during restocking of a tray of a retrograde/anterograde femoral nail (rafn) set on (b)(6) 2018, the tab of the radiolucent insertion handle for expert nails, that keeps the nail from rotating during insertion, was noticed to be missing.There was no patient or surgery involvement.This report is for a radiolucent insertion handle for expert nails/175mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
: dhr review was completed.Part: 03.010.487 lot: 8806961 manufacturing site: (b)(4).Release to warehouse date: 24.July 2014 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 the device history record shows this lot of 10 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked 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 customer quality conducted a review of the provided photograph.Investigation flow: broken.Visual inspection: actual device was not returned.Visual inspection of the complaint device in the file attached to this complaint titled "(b)(4)- email from sales consultant with picture of device" performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.The photo shows that the metallic distal alignment tab/tang has broken off at its base.The broken off tab/tang was not shown in the photo.Document/specification review: the complaint device was manufactured in july 2014.The device history record shows this lot of 10 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.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.Radiolucent insertion handle assembly drawing were reviewed during this investigation.The radiolucent insertion handle is a reusable instrument used during femoral and tibial nail implantations.No product design issues or discrepancies were observed.Dimensional inspection: a relevant dimensional inspection could not be performed at cq because the complaint device was not returned.Material analysis: only top level of the device history record reviewed as sub-components are not lot tracked.A relevant material inspection could not be performed at cq because the complaint device was not returned.Conclusion: a definitive root cause for the device breaking could not be determined based on the provided information.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7724009
• Report Number: 2939274-2018-53092
• Device Sequence Number: 19101585
• Product Code: LXH
• UDI-Device Identifier: 10886982069054
• UDI-Public: (01)10886982069054
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/11/2018

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: 03.010.487
• Device Lot Number: 8806961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1