MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.084
Medical Device Problem Code	Device-Device Incompatibility (2919)
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 devices became stuck.Device is an instrument and is not implanted/explanted.Part: 03.010.084; lot: 1818414; manufacturing site: (b)(4); release to warehouse date: february 08, 2008.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.Investigation flow: device interaction/functional.Visual inspection: the spiral blade inserter was returned unable to disassemble from the aim arm.The hand grip of the spiral blade inserter had many impact marks and spiral blade inserter body is in a fair condition with minimal wear.Based on the visual inspection, the received condition agreed with the complaint description.Functional test: the complaint was able to be replicated with the returned devices as the spiral blade inserter and aim arm are unable to disassemble from each other.No new malfunctions were identified.Dimensional inspection: dimensional analysis was performed on the spiral blade inserter and the outer diameter of the spiral blade inserter body proximal to the stuck region, measured 17.65 mm (ca215) that falls within the specification of 17.64 to 17.68 mm.Document/specifications review: 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.The following drawing(s) was reviewed; spiral blade inserter; spiral blade inserter body.Conclusion: while no definitive root cause could be determined, it is possible that the device encountered unintended forces during its lifetime (10+ years) that could contribute to the complaint condition.Therefore, the complaint is confirmed.During the investigation, no product design issues or manufacturing discrepancies were observed that may have contributed to the complaint condition.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.
Event or Problem Description
It was reported that on (b)(6) 2018 at the sterile processing department, the spiral blade inserter and the spiral blade aiming arm would not come apart.There was no patient involvement.This report is for a spiral blade inserter for retrograde femoral nails-ex.This is report 1 of 2 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.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: SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX
• 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: 7819878
• Report Number: 2939274-2018-53494
• Device Sequence Number: 1392223
• Product Code: LXH
• UDI-Device Identifier: 10886982067548
• UDI-Public: (01)10886982067548
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/02/2018

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: 03.010.084
• Device Lot Number: 1818414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1