MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060233
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition unknown.
Event or Problem Description
The customer reported that during case the lip on the end of the t2 short self holding screwdriver which holds the screw in, broke off.It is unknown on intake whether any unintended metal fell into the patient.Both screw drivers got damaged at the same case.20th feb.Was the op date.There were no damaged items in the patient according to him.There were no delays to the operation as there are spare standard screws drivers in the set which can also be used instead of the self-holding screw drivers.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8445007
• Report Number: 0009610622-2019-00121
• Device Sequence Number: 19580451
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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: 18060233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/22/2019
• 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