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	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.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.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient code (b)(4)-no code available used to capture required intervention.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 patient underwent a hindfoot arthrodesis procedure on (b)(6) 2018.During the procedure, surgeon opted to use the spiral blade inserter for retrograde/antegrade femoral nails (rafn) for insertion of the spiral blade rather than the midfoot/hindfoot spiral blade inserter.During spiral blade insertion, the spiral blade inserter for rafn broke.The spiral blade was removed and then reinserted after additional drilling of the entry site in the calcaneus.It is not known if surgery was delayed due to this issue.Patient status is not known this report is for one (1) spiral blade inserter for retrograde/antegrade femoral nails ex this is report 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.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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
It was reported that the patient underwent a hindfoot arthrodesis procedure on (b)(6) 2018.During the procedure, the spiral blade inserter "sticks" when passing the blade through the aiming arm adapter.The surgeon opted to use the spiral blade inserter for retrograde/antegrade femoral nails (rafn) for insertion of the spiral blade rather than the midfoot/hindfoot spiral blade inserter.It was unknown if there was a surgical delay.The patient status is also unknown.Concomitant device reported: aiming arm for retrograde spiral blade locking (product # 03.010.051, lot # 1784183, quantity 1).
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: part 03.010.084, lot 1784183: manufacturing site: haegendorf.Release to warehouse date: november 29, 2007.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: a product investigation was completed: visual inspection performed at customer quality observed slightly nicked portions on different regions along the spiral pattern of the inserter shaft.However, the subassembly parts that is both the handle and the connecting screw was not returned at customer quality.No signs of breakage were observed on the returned portion (spiral inserter body) of the device.Therefore, initially reported broken complaint condition was unable to be confirmed.However, the functional inspection performed observed that the inserter sticks to aiming arm during its removal at certain portions of its length.Therefore, the stuck complaint condition was confirmed.Relevant drawings for the returned instrument were examined.The diameter of the spiral portion measured and was out of the specification due to the post manufacture damage.Review of the device history records (dhr) showed that there were no issues during the manufacture of this product, including the material and its properties which would contribute to this complaint condition.While no root cause could be determined, it is likely that the age of the device (over 10 years) and unintended excessive forces encountered by the device such as being dropped off during usage/handling could have caused nicked spiral edges which in turn contributed to stuck condition.Also, as the handle portions were not returned, it was unable to be determined if the handle was broken/missing.The insertion and extraction instruments design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of the stuck complaint conditions.During the investigation, no product design or manufacturing issues or 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
While the returned devices were being inspected by the manufacturer, it was noted that the devices are sticking together and few nicked portions were observed on the adapter mating edges.It was determined that the previously reported concomitant aiming arm adapter should be added as a complained device.This is report 1 of 2 for (b)(4).

• 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: 7511846
• Report Number: 2939274-2018-52166
• Device Sequence Number: 1898393
• Product Code: LXH
• UDI-Device Identifier: 10886982067548
• UDI-Public: (01)10886982067548
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.084
• Device Lot Number: 1784183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 04/22/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 06/19/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 06/05/2018; 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention