MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SPEEDLOCK SLEEVE GAMMA3® 180; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13201118
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
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.".
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.A physical device inspection was not possible since the affected device was not returned and only the pictures were shared by the customer.Through the images provided of the reported device, the knob can be seen in a broken state.Some material has also chipped off which indicates towards quite an intense external impact on it during the surgery.The device appears to be in long and frequent use as evident by the general faded appearance of it.Based on the information gathered, the root cause of the failure is related to an inadequate handling by the user, also involving an off-label use.With the visible information gathered from the device (faded appearance & scratches) it can be said that the product had been long in use, therefore it is safe to say that it had fulfilled its tasks in former surgeries as intended as there is no prior complaint reported with the same lot.But in this case, a struggle was there to disassemble the assembly that possibly involved hammering.This surpassed the ultimate rupture strength of the device which it can bear (weakening of structural strength is also possible due to fatigue caused by frequent usage and multiple sterilization cycles).Ultimately, speedlock sleeve broke, breaking along the locks at the distal part of the target device as well.Under intended usage such a failure would not have occurred this is the first reported case with this lot number.A review of labelling did not indicate any abnormalities.The instruction for use was reviewed: ¿¿ only use the instrument for its intended purpose as described in the operative technique for the product system.Off-label use of an instrument can harm the patient and/or impair the function and integrity of the instrument.¿ do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! ¿ during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ the cleaning and sterilization guide provides instructions that: ¿stryker trauma & extremities typically does not specify the maximum number of uses appropriate for reusable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SPEEDLOCK SLEEVE GAMMA3® 180
• 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: 9143473
• Report Number: 0009610622-2019-00797
• Device Sequence Number: 19348733
• Product Code: LXH
• UDI-Device Identifier: 07613154893652
• UDI-Public: 07613154893652
• 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): 12/03/2019

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: 13201118
• Device Lot Number: KP348362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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