MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROTECT SLEEVE 11/8 L188; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.025.040
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a tfna procedure on (b)(6) 2017 a physician struggled to get a distal locking screw to pass through a short tfna nail.The screw was not entering into the nail at the right angle.The procedure was successfully completed using the reported devices.There was no reported surgical delay.The patient was reported to be in good condition following the procedure.Reported concomitant devices: unknown tfna short nail, lot number unknown, quantity 1.This report involves (3) device.(b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part no.: 03.025.040, lot no.: 9045569 , manufacturing location: (b)(4), release to warehouse date: 21.Aug.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.
Additional Manufacturer Narrative
Product was not returned.A review of photos provided relevant to this device was performed.Visual inspection of the provided photos revealed no evidence of misalignment, and no damage or wear that would contribute to a misalignment.Therefore, the reported complaint condition was not able to be confirmed.A dimensional inspection could not be performed because the device was not returned.Replication of the reported complaint condition at customer quality (cq) via functional test is not possible because the device was not returned.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant protection sleeve drawings were reviewed during this investigation.No product design issues or discrepancies were observed.No manufacturing discrepancies or design issues were identified as a result of this investigation and the device was not returned for 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: PROTECT SLEEVE 11/8 L188
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7284073
• Report Number: 8030965-2018-51256
• Device Sequence Number: 13747350
• Product Code: LXH
• UDI-Device Identifier: 10886982069900
• UDI-Public: (01)10886982069900(10)9045569
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/24/2018

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: 03.025.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 04/06/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/01/2018; 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1