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

Catalog Number	03.401.072
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: may 19, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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
It was reported that during revision surgery on (b)(6) 2017, the screw head of the connecting bolt on the stem extractor instrument broke off.The patient was initially implanted with epoca shoulder implants on the right side on an unknown date.Due to an insufficient rotator cuff, the patient was returned to surgery on (b)(6) 2017 for revision to a competitor's total shoulder construct.While surgeon was tightening a bolt to the stem, the screw head of the connecting bolt on the stem extractor broke off.The fragments were easily removed.The surgeon was able to complete the procedure using surgical pliers.The procedure was delayed approximately two (2) minutes due to this issue but was completed successfully.Concomitant devices reported: bolt (part number unknown, lot number unknown, quantity 1) this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a product investigation was performed.The 03.401.072 lot number 14-1085 stem extractor was returned and reported to have broken during surgery.This complaint condition was likely caused by overtightening of the set screw; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.The 03.401.072 stem extractor is an instrument routinely used in the epoca revision instrument set (per relevant technique guide).The device was returned and reported to have broken during surgery.This condition is confirmed; the proximal head of the set screw that tightens into the implant is entirely ripped off leaving a jagged circular fracture surface.It is likely that the set screw was overtightened which has led to this complaint condition.The implant likely had some bone growth into the threads which may have caused the set screw to not fully seat.The device was manufactured in 5/2014 and is over two years old.The balance of the returned device is in fair condition with some markings along the distal surface.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.It is likely that the set screw was overtightened which has led to this complaint condition.The implant likely had some bone growth into the threads which may have caused the set screw to not fully seat.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Patient weight is not available for reporting.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: 6306269
• Report Number: 3000270450-2017-10034
• Device Sequence Number: 13467281
• Product Code: HWB
• UDI-Device Identifier: 10886982079824
• UDI-Public: (01)10886982079824(10)14-1085
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 01/16/2017

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: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/14/2017
• 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: UNKNOWN BOLT, QUANTITY 1
• Patient Age: 73 YR