MAUDE Adverse Event Report: STRYKER GMBH ELASTOSIL HAMMER-HANDLE ASNIS III LARGE AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	702630
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.  if additional information becomes available it will be provided on a supplemental report.Device not available to stryker.
Event or Problem Description
As reported in medwatch (b)(4): "during the surgery, the extractor driver tip had broken into the screw [head].A very small portion of the extractor driver tip that chipped off (1mm in length) was noted to be visible in fluoroscopy.The surgeon was informed and attempted to explore the wound to remove the object but the very small object was not located".Additional information received from the risk manager indicated that there was revision surgery due to pain which will be reported under stryker (b)(4).
Additional Manufacturer Narrative
The reported event that cannulated tap ø6.5mm for screws ø6.5mm large ao fitting was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by an over torque on the device, which is typical on an extraction phase.As a reminder, it is said in the ifu: "''ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument; please remember that product systems may be subject to alterations that affect the compatibility of the instrument with other instruments or with implants.Special comments for application ¿ only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.¿ always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The visual inspection of the picture of the device received from the customer confirms the failure mode.It can be noticed that the cannulated tap is indeed broken on the level of its threaded part.The fracture at the tip of the device follows an helix shape, which is proper to a over torque applied to the instrument.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported in medwatch 0501160000-2018-8004: "during the surgery, the extractor driver tip had broken into the screw [head].A very small portion of the extractor driver tip that chipped off (1mm in length) was noted to be visible in fluoroscopy.The surgeon was informed and attempted to explore the wound to remove the object but the very small object was not located".Additional information received from the risk manager indicated that there was revision surgery due to pain which will be reported under stryker pi 1770751.

• Brand Name: ELASTOSIL HAMMER-HANDLE ASNIS III LARGE AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7428347
• Report Number: 0008031020-2018-00294
• Device Sequence Number: 1592454
• Product Code: LXH
• UDI-Device Identifier: 04546540112934
• UDI-Public: (01)04546540112934
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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 Model Number: 702630
• Device Catalogue Number: 702630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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
• Patient Age: 13 YR
• Patient Weight: 73