MAUDE Adverse Event Report: SYNTHES SELZACH STEM EXTRACTOR F/GUIDE BAR NO. 03.401.07

Catalog Number	03.401.072
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 review was conducted.The report indicates that the: dhr review for: part 03.401.072 / 12-2707; manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 15.June 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 or Problem Description
Device report from synthes on an event in (b)(6) as follows: it was reported that a removal surgery of the epoca prosthesis took place on (b)(6) 2017.The stem extractor was connected to the stem with the connecting screw.During removal of the stem the connecting screw broke.The surgery was prolonged about 20 minutes.No information about patient condition and outcome available.The procedure was a planned epoca removal surgery and after implantation of an inverse prosthesis.There was no patient harm and the outcome was good.The epoca stem was removed about 20 minutes later.All broken off pieces were removed and the procedure was successfully completed.This complaint involves 1 part.Concomitant reported part: 1x epoca stem (part and lot unknown) this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A manufacturing evaluation and product investigation were completed: the investigation has shown that the screw of the stem extractor is broken just below the screw head; the screw head as well as the screw shaft were returned.The stem extractor shows normal signs of use.The review of the production histories revealed that this instrument was manufactured in june 2012 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Also the hardness was measured during manufacturing and was found to be good.The dimensions of the returned screw were checked as far as measurable and were found to comply with the specifications.The broken surface is homogenous what indicates material conformity as well.No manufacturing related issues that would have contributed to this complaint were found.No manufacturing related issue was identified and/or confirmed.No definitive root cause was able to be determined; however the failure is most likely a result of fatigue and overload.No product related issues were 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: STEM EXTRACTOR F/GUIDE BAR NO. 03.401.07
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6298833
• Report Number: 3000270450-2017-10033
• Device Sequence Number: 13532210
• Product Code: HWB
• UDI-Device Identifier: 07611819408692
• UDI-Public: (01)07611819408692(10)12-2707
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: 03.401.072
• Device Lot Number: 12-2707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1X EPOCA STEM (PART AND LOT UNKNOWN)