MAUDE Adverse Event Report: SYNTHES BETTLACH 4.3MM THREADED LCP(TM) DRILL GUIDE

Catalog Number 323.042-EXS

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial hospital contact telephone is not available for reporting.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.Manufacturing location: (b)(4).Manufacturing date: 01.March 2007.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the reported device was used in surgery for femur trochanteric occult fracture on (b)(6) 2017.When the surgeon tried to drill the bone after attaching the drill guide to the plate, the drill guide was broken.The surgeon then took the drill guide out and confirmed that all the broken pieces had been retrieved.The surgery was completed safely by using another drill guide.Surgeon noted that extra force might have been applied on the device during drilling since the drill guide had been attached diagonally to the plate.The surgery was extended but unknown how many minutes.No adverse consequence to the patient was reported.Patient outcome is good; procedure was successfully completed with no other medical intervention.Concomitant devices reported: plate (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.3mm threaded lcp drill guide.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the visual inspection of the returned lcp drill sleeve 5.0, f/drill bits ø 4.3m has shown that a part of the threaded tip section is broken out.Additional there are some small scratches detected.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.This part was manufactured in march 2007 and is now more than 10 years old.As already mentioned in the complaint description, it is likely that a mechanical overload situation for example lateral stress has led to the breakage.Based on these findings we conclude that the cause of the breakage is not due to any manufacturing non-conformances.The relevant dimensions were measured and passed.No indication for product related issue was found.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: 4.3MM THREADED LCP(TM) DRILL GUIDE
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6689164
• MDR Text Key: 79273668
• Report Number: 9612488-2017-10301
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819246607
• UDI-Public: (01)07611819246607(10)2240165
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.042-EXS
• Device Lot Number: 2240165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• 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