MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48328500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the doctor placed the screwdriver into guide, a snap was heard.He removed the broken pieces and tried again with a second driver, that also snapped.The procedure was successfully completed with another screwdriver in the set.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The instrument was not returned for evaluation as the hospital disposed of the screwdrivers post surgery but the reported issue was confirmed via communication with the sales rep.Since no lot number was provided manufacturing records of the device could not be reviewed and the age of the device is unknown.It is inconclusive how many times the instrument has been used.The plausible root cause of the reported event could not be determined conclusively.
Event or Problem Description
It was reported that when the doctor placed the screwdriver into guide, a snap was heard.He removed the broken pieces and tried again with a second driver, that also snapped.The procedure was successfully completed with another screwdriver in the set.There are no reports of adverse consequences to the patient.

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7615994
• Report Number: 0009617544-2018-00146
• Device Sequence Number: 16619196
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: No Information
• Device Model Number: 48328500
• Device Catalogue Number: 48328500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1