MAUDE Adverse Event Report: SYNTHES BETTLACH PULL REDUCTION INSTRUMENT FOR LISS; GUIDE

Catalog Number	324.033
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.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 review was conducted.The report indicates that: part #324.033, lot # is 9738420.Manufacturing location: (b)(4).Manufacturing date: 10.December 2015.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 or Problem Description
Device report from synthes on an event in (b)(6) as follows: it was reported that the pulling device was found broken at the loan department.No patient involvement.This complaint involves one part.This report is 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the investigation of the complained pulling device, has shown that approximately 60 mm from the tip section broke off.Further investigation has shown that the cutting edges of the drill are worn out.Because of the damage the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Lot 9738420 was manufactured in december 2015.The hardness of material was within the specification.The broken surface is homogenous what indicates material conformity as well.Unfortunately we are not able to determine the exact cause of the breakage.It is likely that a mechanical overload by applying to much force during a pulling maneuver did lead to this breakage, this would also explain the clearly visible heavy stress marks at the bottom of the nut.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.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: PULL REDUCTION INSTRUMENT FOR LISS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6218243
• Report Number: 9612488-2017-10001
• Device Sequence Number: 784673
• Product Code: FZX
• UDI-Device Identifier: 07611819221345
• UDI-Public: (01)07611819221345(10)9738420
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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: 324.033
• Device Lot Number: 9738420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1