MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X50MM TL17MM; SCREW, FIXATION, BONE

Model Number	325050
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "(b)(6) patient with medial epicondyle fracture.Surgeon utilizing an asnis ss 4.0 cannulated screw.The surgeon put the screw into the patient and upon x-ray, noted that the threads of the asnis cannulated screw stripped off the screw.The surgeon immediately removed the screw and implanted another one (ref # 604650, asnis ti 4.0x50mm pt screw).".
Additional Manufacturer Narrative
Please refer to h6 results & conclusion codes.The reported event could be confirmed with the help of x-rays provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The optech states that: ¿contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.Note: in dense bone, puncturing the cortex with the ø1.4 x 150mm drill bit to initiate the wire may reduce heat build-up and/or deflection of the wire.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿the choice of treatment is okay with this kind of injury.Whether this was processed correctly cannot be said with the given information.The x-rays confirm the event of screw breakage.Potentially hard bone is a factor, possibly a conflict with the k-wire is also part of the problem.The screw cuts partially into these and may damage or be damaged.Probably some conflict with the k-wire together with a contact to the very hard bone may have led to this outcome.¿ based on investigation, the root cause was attributed primarily to a user related issue along with secondary patient factor i.E.Hard bone.The optech states ¿ contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.¿ the medical opinion also states ¿the failure was caused due to some conflict with the k-wire together with a contact to the very hard bone¿.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "11 year-old patient with medial epicondyle fracture.Surgeon utilizing an asnis ss 4.0 cannulated screw.The surgeon put the screw into the patient and upon x-ray, noted that the threads of the asnis cannulated screw stripped off the screw.The surgeon immediately removed the screw and implanted another one (ref # 604650, asnis ti 4.0x50mm pt screw).".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X50MM TL17MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11372851
• Report Number: 0008031020-2021-00064
• Device Sequence Number: 3865688
• Product Code: HWC
• UDI-Device Identifier: 07613327078015
• UDI-Public: 07613327078015
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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 Model Number: 325050
• Device Catalogue Number: 325050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR