MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE; GUIDE

Catalog Number	03.010.044
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.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.No 510k in jde, trm part is not available.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a connecting screw from tibia-ex nail is difficult to screw/unscrew.No further information provided.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: lot number, date returned to manufacturer, facility name, address, telephone.Initial reporter occupation, date of manufacture.Subject device has been received and is currently in the evaluation process.Corrected data: 510k.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
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.Dhr review was completed.Part # 03.010.044 , synthes lot # u216997 , supplier lot # u216997 , release to warehouse date: 09oct2015 and 09dec2014 , supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.This complaint is confirmed.The returned device was evaluated at customer quality (cq) and visual inspection revealed post manufacturing wear and damage in the form of a flat/malformed/stripped threadform which would contribute to the reported complaint condition of difficulty during use.It was also noticed that the part # and lot# etch are worn off and barely legible.Replication of the complaint condition via functional test was not able to be performed because the nail was not returned.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Drawing for the device was reviewed, and no drawing issues or discrepancies were noted.The design is determined to be adequate for its intended use and did not contribute to this complaint condition.The 03.010.044 cannulated connecting screws are reusable instruments of intramedually nail insertion procedures and are used to connect the insertion handle with the proximal end of the nail for stable insertion or attempted nail explantation.A dimensional inspection was not able to be performed at cq because of the post manufacturing damage.The most likely cause for this complaint is cross threading with a nail thread and applying torque resulting in damage to threadform.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: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7364590
• Report Number: 2939274-2018-51197
• Device Sequence Number: 11081192
• Product Code: FZX
• UDI-Device Identifier: 10886982067166
• UDI-Public: (01)10886982067166(10)LOTNUMBERUNK
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 03.010.044
• Device Lot Number: U216997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 05/11/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/10/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1