MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERT-HANDLE F/EXPERT TN+FN; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.010.045

Device Problems Break (1069); Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown if patient was involved; patient information not available for reporting.Unknown if the issue was detected pre-operatively or intra-operatively.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: 03.010.045/ 7751732.Manufacturing location: (b)(4).Manufacturing date: 20 feb 2012.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the insertion handle has a broken at the neck.The instrument can no longer be connected to the nail and the connecting screw.It is not known if the issue was detected pre-operatively or intra-operatively.Complaint involves 1 part.Concomitant reported parts: 1x unknown connecting screw; 1x unknown nail.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A customer quality (cq) investigation was performed for the subject device (insert-handle f/expert tn+fn, part number 03.010.045, lot number 7751732).The investigation has shown that the nose on the handle is broken off.The missing fragment was not sent back for investigation.There are also marks on the entire surface visible.The review of the production history revealed that this insertion handle was manufactured in february 2012 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances and we can only assume that high applied torsional force caused this damage.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use, the complaint is determined not to be a result of a detected product related deficiency.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 F/EXPERT TN+FN
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6754477
• MDR Text Key: 81583201
• Report Number: 3003875359-2017-10372
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819760837
• UDI-Public: (01)07611819760837(10)7751732
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.045
• Device Lot Number: 7751732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2012
• 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