MAUDE Adverse Event Report: STRYKER GMBH ELASTOSIL T-HANDLE LARGE AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702628
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The rubber coating around the cannula comes off.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the silicone on the proximal side of the device, where the "do not hit" is marked is starting to come off.This case can be classified as normal wear related.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 rubber coating around the cannula comes off.

• Brand Name: ELASTOSIL T-HANDLE 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: 9748400
• Report Number: 0008031020-2020-00514
• Device Sequence Number: 13635154
• Product Code: LXH
• UDI-Device Identifier: 04546540112910
• UDI-Public: 04546540112910
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 702628
• Device Catalogue Number: 702628
• Device Lot Number: P19479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1