MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNIVERSAL WIRE/PIN COLLET; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	4500-125-000
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Appropriate term/code not available chosen as there was a misplaced pin found in post operative imaging that had to be corrected with additional surgery.
Event or Problem Description
The user facility reported that the device pin was wobbling during procedure.  the surgeon used the collet despite the wobbling.After the surgery, the postoperative image showed that the pin was out of alignment by about 5mm.A new surgery was performed to correct this.
Event or Problem Description
The user facility reported, that the device pin was wobbling, during procedure.  the surgeon used the collet, despite the wobbling.After the surgery, the postoperative image showed, that the pin was out of alignment by about 5mm.A new surgery was performed to correct this.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted, to document device evaluation results.

• Brand Name: UNIVERSAL WIRE/PIN COLLET
• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12418722
• Report Number: 3015967359-2021-01944
• Device Sequence Number: 3536606
• Product Code: HWE
• UDI-Device Identifier: 07613327467468
• UDI-Public: 07613327467468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4500-125-000
• Device Catalogue Number: 4500125000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown