MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REDUCTION TOOL F/SPONDYLOLISTH; INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 03.628.104

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The 510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was conducted.The report indicates that the: part number: 03.628.104.Synthes lot number: 8324766.Release to warehouse date: 22.Jul.2013.Manufacturing site: (b)(4).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 from the loan set department, that during inspection orthokit specialist found two broken instruments on both tools there is no working thread, broken parts are not returned.No patient involvement.This complaint involves 2 parts.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: reporter phone number.(b)(4).Device history records review was incorrectly reported for incorrect lot# in the initial report.Correct device history records review will be reported upon 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.

Manufacturer Narrative

Part number 03.628.104, lot number 7946876: release to warehouse date: august 29, 2012.Manufacturing site: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the visual inspection of the returned reduction tool f/spondylolisthesis has shown strong wear marks on the surface of the instrument.Additionally, the threaded tip section is completely broken off.The review of the production history revealed that this instrument was manufactured in august 2012 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.The measurements of the hardness after the hardening procedure were also within the specification.The used material was stainless steel 1.4542 as required.Unfortunately, we are not able to determine the exact cause which has led to this occurrence.It is likely that too much mechanical force had been applied during use.(b)(4).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: REDUCTION TOOL F/SPONDYLOLISTH
• Type of Device: INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7319073
• MDR Text Key: 101862134
• Report Number: 8030965-2018-51789
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819475915
• UDI-Public: (01)07611819475915(10)7946876
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.628.104
• Device Lot Number: 7946876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/06/2018; 04/23/2018
• Supplement Dates FDA Received: 04/03/2018; 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1