MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702496
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
When the asnis 4.0 was removed , the head was stripped.Therefore, the extractor was inserted into the asnis screw, but the extractor was broken to put torque.After that, the asnis and the tip of the extractor was left in the patient body.
Event or Problem Description
When the asnis 4.0 was removed, the head was stripped.Therefore, the extractor was inserted into the asnis screw, but the extractor was broken to put torque.After that, the asnis and the tip of the extractor was left in the patient body.
Additional Manufacturer Narrative
The reported event that extractor asnis iii for screws: ø4.0mm ao fitting was alleged of issue (breakage during surgery) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.Visual inspection of the returned device confirmed that the tip of the extractor was broken.The broken piece was not returned.Based on the visual inspection of fractured surface it can be concluded that the product has undergone typical fracture of torsional overloading.Dimensional inspection was not carried out, however, dhr was reviewed and during manufacturing, functionality test and dimensional inspection were done according to specifications and all devices met the specifications.Thus, based on the investigation, the most likely root cause is attributable to a user (us) related issue.The breakage was caused by applying excessive force.As already stated in implant extraction set (optech), assemble the selected conical extractor (male) with the teardrop-handle and turn it counter-clockwise while applying pressure in line with the screw axis, extracting the screw at the same time.If the screw does not come completely out, the forceps can be used to complete the extraction.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7691944
• Report Number: 0008031020-2018-00507
• Device Sequence Number: 19015622
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: 04546540112415
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 702496
• Device Lot Number: 01239Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other