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

Model Number	03.010.084
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.The investigation could not be completed; 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 or Problem Description
Libertas: it was reported that on (b)(6) 2019, a spiral blade inserter for retrograde femoral nail was noted to be broken during reverse logistics audit of the returned devices at (b)(6).There was no patient involvement and no additional information is available.This complaint involves one (1) device.This report is for one (1) spiral blade inserter for retrograde femoral nails-ex.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d8.H3, h6: a product investigation was conducted.Visual inspection: visual inspection performed at customer quality (cq) identified nothing is broken from the device.The device is still intact, there are some wear marks that would not impact the functionality of the device.No new issues were identified.A device failure was not identified.Document specification: the relevant documents were reviewed as part of this investigation: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation revealed one nonconformity: material record review (mrr).This mrr did not contribute to the complaint condition, and this lot met all dimensional, visual and packaging criteria at the time of release.Investigation conclusion: no definitive root cause was able to be determined as the complaint is unconfirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.010.084.Lot number: 4796339.Part manufacture date: 10/29/2004.Manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: mrr.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of spiral blade inserter for retrograde femoral nails-ex was processed through the normal manufacturing and inspection operations with no rework noted.There were nonconformity issues documented on material record review (mrr): specifically, visual nonconformities and incorrect material certifications.None of these issues contributed to the complaint condition.All nonconformities were accepted with the required approvals.This lot met all dimensional, visual and packaging criteria at the time of release with no additional issues documented during the manufacture that would contribute to this complaint condition.The review of the device history record revealed one nonconformity mrr: this mrr did not contribute to the complaint condition, and this lot met all dimensional, visual and packaging criteria at the time of release.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: SURGICAL, MISC, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9639724
• Report Number: 2939274-2020-00501
• Device Sequence Number: 2799783
• Product Code: LXH
• UDI-Device Identifier: 10886982067548
• UDI-Public: (01)10886982067548
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.084
• Device Catalogue Number: 03.010.084
• Device Lot Number: 4796339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1