MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3® 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "during an insertion of a long gamma nail, the surgeon needed to back out nail for correct lag screw position.When trying to remove nail holding bolt, surgeon noticed bolt was compromised.Surgeon struggled to get bolt off targeter, surgical tech could not separate sleeve from targeter.She stated to me it was stuck, she pulled apart and plastic pieces flew everywhere.".
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but images were provided for evaluation.A physical device inspection was not possible since the affected device was not returned and only the pictures were shared by the customer.Based on the images received, the nail holding bolt has deformed and worn out surface of the bolt could be observed.Some part of the nail holding screw is completely chipped off indicating use of intense force to remove the nail the holding screw.Based on the above investigation, the root cause of the failure is not related to deficiency of the device but is rather considered to be an off-label use by the user.Nail holding screws are not meant to be hit even for removal.As the device had been in use for a long time (manufactured in 2006), it can be safely said that it had fulfilled its tasks in former surgeries as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of labelling did not indicate any abnormalities.The instruction for use states: ¿do not hit instruments unless they are specifically intended for impaction.¿ no indications of manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during an insertion of a long gamma nail, the surgeon needed to back out nail for correct lag screw position.When trying to remove nail holding bolt, surgeon noticed bolt was compromised.Surgeon struggled to get bolt off targeter, surgical tech could not separate sleeve from targeter.She stated to me it was stuck, she pulled apart and plastic pieces flew everywhere.".

• Brand Name: NAIL HOLDING SCREW GAMMA3® 8X35MM
• 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: 9143471
• Report Number: 0009610622-2019-00798
• Device Sequence Number: 11196246
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 13200090
• Device Lot Number: K819201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR