MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:Ø5.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702497
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The doctor confirmed that bone union, so deployed two assnis 4.0 screws were tried to remove with extractor.However these were not able to be removed and the tip of the extractor was broken and left in the patient body.The tip of the extractor was left in the patient body.The screws were not removed.
Additional Manufacturer Narrative
The reported event that extractor asnis iii for screws:ø4.0mm ao fitting was alleged of 'breakage during surgery' could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.The device inspection revealed the following: the returned product revealed broken tip.A deeper anaylsis of the tip surface shows that the device broke in torsion, since the breakage lines are following a helicoidal pattern, which is typical of a torsional overloading.Thus, based on the investigation, the most likely root cause is attributable to a user related issue.The breakage was caused by applying excessive force.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The doctor confirmed that bone union, so deployed two assnis 4.0 screws were tried to remove with extractor.However these were not able to be removed and the tip of the extractor was broken and left in the patient body.The tip of the extractor was left in the patient body.The screws were not removed.

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:Ø5.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8210625
• Report Number: 0008031020-2019-00003
• Device Sequence Number: 16863820
• Product Code: LXH
• UDI-Device Identifier: 04546540112422
• UDI-Public: 04546540112422
• 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): 02/21/2019

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: 702497
• Device Lot Number: 02456V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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