MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC INSERT-HANDLE RADIOLUC L175; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.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.Telephone number and address us unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was requested.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 a patient underwent an unknown procedure on (b)(6) 2018.Towards the end of the surgery, the surgeon was impacting the driving cap with the radiolucent insertion handle.The radiolucent insertion handle broke at the handle.The surgery was pretty much complete when this happened, therefore there was no impact on patient nor any time delay reported.No other instruments or additional medical intervention required.He has no patient information available and no additional information available at this time.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
It has been determined at customer quality that the original alleged device has been found with no allegations and the actual complained device should be the driving cap (ip-00167543).Product code: 03.010.487, lot # :8806946 was returned as a concomitant device without an alleged complaint condition.Upon visual inspection, there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.The results of the investigation are pending final 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.
Additional Manufacturer Narrative
(b)(4) was submitted without a date.Correct date should have been 3/19/2018 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
Dhr review was completed.Part no.: 03.010.487.Lot no.: 8806946.Manufacturing location: (b)(4).Release to warehouse date: 21.Mar.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.Customer quality conducted an investigation of the returned device.The returned (b)(4) insertion handle was examined and the complaint condition of broken was not able to be confirmed.This device is not broken.Rather, the tip of the driving cap that broke in this complaint event is lodged inside this insertion handle.The complaint condition was unable to be replicated due to post-manufacturing damage.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.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings for the returned instrument were reviewed (both current and from the time of manufacture): top-level.No design issues or discrepancies were identified.No dimensional analysis is applicable as this device is not broken (rather it has a portion of another broken instrument lodged inside it).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: INSERT-HANDLE RADIOLUC L175
• 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: 7260658
• Report Number: 2939274-2018-50577
• Device Sequence Number: 11021814
• Product Code: LXH
• UDI-Device Identifier: 10886982069054
• UDI-Public: (01)10886982069054(10)8806946
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/19/2018

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: 03.010.487
• Device Lot Number: 8806946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 02/13/2018; 03/20/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/14/2018; 03/19/2018; 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1