MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PIN COLLET (2.0-3.2MM); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7203126000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 5 events were reported for this quarter.Product return status: 5 device investigation types have not yet been determined.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.5 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 5 previously reported events are included in this follow-up record.Product return status 3 devices were received.2 device investigation types have not yet been determined.Event confirmation status 3 reported events were confirmed.Evaluation results 3 devices were found to be affected by metal shavings.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.5 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 5 previously reported events are included in this follow-up record.Product return status: 4 devices were received.1 device was not available for evaluation.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.5 events had no patient involvement; no patient impact.

• Brand Name: PIN COLLET (2.0-3.2MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 9636618
• Report Number: 0001811755-2020-00223
• Device Sequence Number: 16238114
• Product Code: HWE
• UDI-Device Identifier: 04546540640185
• UDI-Public: 04546540640185
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: No Information
• Device Model Number: 7203126000
• Device Catalogue Number: 7203126000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/29/2020; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1