MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.012

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

Patient¿s height reported as 5 feet 7 inches.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 Description

It was reported that an initial surgery for trochanteric nail fixation ¿ advanced (tfna), was performed on (b)(6) 2018.During the surgery, as the surgeon attempted to align the nail with the insertion handle, the distal tang of the insertion handle was found to be bent.A new insertion handle was retrieved from another set to complete the procedure which caused a 5-minute surgical delay.The surgery was completed successfully and the patient is reported to be in stable condition.Concomitant devices reported: tfna nail (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed for part no.: 03.037.012, lot no.: 9362070: manufacturing location: (b)(4), release to warehouse date: 12.Mar.2015: no non-conformance reports (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.A product investigation was performed.The returned insertion handle (part: 03.037.012, lot: 9362070, mfg: 12-mar-2015) was inspected at customer quality and the complaint of bent tip was confirmed.Visual inspection performed at customer quality observed that the tip of the insertion handle was bent both outward and sideways.No new malfunction was identified.Whether this complaint could be replicated is not applicable because the device was returned bent.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for insertion handle and determined to be suitable for the intended design and application when used as recommended.Dimensional analysis performed for the width of the distal tab of the insertion handle measured and is within specifications.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during its usage or handling could have led to the complaint condition.During the investigation, no product design 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.

• Brand Name: COMPLETE RADIOLUCENT INSERTION HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7363931
• MDR Text Key: 103281337
• Report Number: 2939274-2018-51187
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070289
• UDI-Public: (01)10886982070289(10)9362070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.012
• Device Catalogue Number: 03.037.012
• Device Lot Number: 9362070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 78