MAUDE Adverse Event Report: SYNTHES SELZACH STEM EXTRACTOR F/GUIDE BAR 03.401.070

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	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient dob & weight not provided for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: part 03.401.072; lot 14-1085, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 19.May.2014.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
During the a revision surgery on (b)(6) 2017, the epoca stem extractor's connection screw disengaged and broke off the extraction assembly.The stem extra extractor had been secured to the stem for removal.After repeated slapping with the back hammer the epoca stem would not back out of the bone and the connecting screw disengaged and broke in half.It was noted the epoca coating appeared to be embedded in the humerus.Half of the screw broke off the operating field and the other half remained in the epoca stem which was removed by hand.No fragments were left behind in the patient.Additional medical intervention was required.The surgeon used flexible chisel and saw to loosen the stem from the bone.A surgical delay of 10 minutes was noted due to the extra medical intervention required to remove the stem.The patient was revised to a tornier reverse shoulder (tsa) procedure was completed successfully.This complaint involves 1 device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Return to manufacturer.Subject device has been received and is currently in the evaluation process.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.
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, device history records (dhr) review and drawing review were performed as part of this investigation.Visual inspection of the stem extractor showed the extraction threads are deformed and contained chips and burrs.This complaint is confirmed.The m6x18 screw was not returned with the device.This complaint cannot be replicated at customer quality (cq) because not all the mating parts used during the surgery were returned.Drawings were reviewed and verified the returned device met the manufacturing print.No definite root cause can be determined.During the investigation, no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.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 03.401.070
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6788035
• Report Number: 3000270450-2017-10283
• Device Sequence Number: 13485898
• Product Code: HWB
• UDI-Device Identifier: 10886982079824
• UDI-Public: (01)10886982079824(10)14-1085
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2017

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: 14-1085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 09/05/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 09/01/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR