MAUDE Adverse Event Report: STRYKER GMBH CROSS-PLATE REAMER ANCHORAGE; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	XFR006100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
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
When over-drilling with the recessed cutters, abrasion was detected in the anchorage system.There were no special measures to complete the medical procedure successfully.The abrasion was only removed.
Event or Problem Description
When over-drilling with the recessed cutters, abrasion was detected in the anchorage system.There were no special measures to complete the medical procedure successfully.The abrasion was only removed.
Additional Manufacturer Narrative
Correction: section concomitant medical products and device evaluated by mfr.The reported event that cross-plate reamer anchorage was alleged of 'device damaged' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.If any further information is provided, the investigation report will be updated.H3 other text : device was discarded.

• Brand Name: CROSS-PLATE REAMER ANCHORAGE
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8341360
• Report Number: 0008031020-2019-00065
• Device Sequence Number: 11355583
• Product Code: HWE
• UDI-Device Identifier: 07613252265771
• UDI-Public: 07613252265771
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/04/2019

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: XFR006100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 85