MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING; GUIDE

Catalog Number	03.010.051
Medical Device Problem Code	Mechanical Jam (2983)
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 is unknown.Device is an instrument and is not implanted/explanted.Part 03.010.051, lot 1814506: manufacturing site: (b)(4).Release to warehouse date: march 19, 2008.The device history record shows this lot of pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.A product investigation was completed: the returned threaded drill was inspected and the complaint was confirmed.Visual inspection performed at customer quality observed slightly nicked portions on inner region of aiming arm cannulation along its mating edge to the inserter shaft.Also, the functional inspection performed observed that the inserter sticks to aiming arm during its removal at certain portions of its length which could possibly be the result of nicked surfaces on both the devices.Therefore, the stuck complaint condition was confirmed.Relevant drawings for the returned instrument were examined.The diameter of the cannulation for spiral inserter measured and was within the specification.Review of the device history record(s) 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 during usage/handling could have caused nicked edges which in turn contributed to stuck condition.The guiding blocks and aiming instruments design and clinical risk management (dcrm) document was reviewed 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
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 was also noted, 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 is not known if surgery was delayed due to this issue.Patient status is not known.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 2 of 2 for (b)(4).

• Brand Name: AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7624829
• Report Number: 2939274-2018-52575
• Device Sequence Number: 16463053
• Product Code: FZX
• UDI-Device Identifier: 10886982067234
• UDI-Public: (01)10886982067234
• 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
• 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: 03.010.051
• Device Lot Number: 1814506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 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