MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO FITTING; PLATE, FIXATION, BONE

Catalog Number	703713
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Tried to pull out the first screw manually at the time of operation of the navel clippers nail, the tip of the driver broke.Finished the procedure with a substitute driver.The broken tip was removed out of patient body.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
Tried to pull out the first screw manually at the time of operation of the navel clippers nail, the tip of the driver broke.Finished the procedure with a substitute driver.The broken tip was removed out of patient body.

• Brand Name: SCREWDRIVER BLADE T10 AO FITTING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7784907
• Report Number: 0008031020-2018-00559
• Device Sequence Number: 1117134
• Product Code: HRS
• UDI-Device Identifier: 04546540687647
• UDI-Public: 04546540687647
• Combination Product (Y/N): N
• PMA/510(K) Number: K170727
• 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): 11/12/2018

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 Catalogue Number: 703713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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