MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, COMPRESSION S2 Ø9X330 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	17250933S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The pharmacist at the hospital reported the following event: "the nail was installed due to a long spiral fracture of the right leg.After a x-ray check up during the intervention, the surgeon noticed that the nail was bented and replaced it right away by an nail of 10mm instead of 9mm.
Event or Problem Description
The pharmacist at the hospital reported the following event: "the nail was installed due to a long spiral fracture of the right leg.After a x-ray check up during the intervention, the surgeon noticed that the nail was bented and replaced it right away by an nail of 10mm instead of 9mm".
Additional Manufacturer Narrative
The reported event that the nail was bent was not confirmed.In the case presented a compression nail with diameter 9 mm was revised with a similar nail with 10 mm after 3 days of implantation; allegedly due to nail bending.The returned nail corresponds in all aspects to the required dimensions ¿ including nail bending at proximal and distal.The alleged deviation ¿bent nail¿ (after 3 days) was not confirmed.Review of complaint history, capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated potential non-function was addressed adequately.There were no actions in place related to the reported event for the subject product.The labelling points describes the implant features and how to proceed during surgery in detail.With above, restricted information it was concluded that the complained nail was not suitable for the anatomical requirement.Thus, the cause of the event was potentially originated by a lack of knowledge.Above information did not verify any deficiency in the nail.

• Brand Name: TIBIAL NAIL, COMPRESSION S2 Ø9X330 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7691483
• Report Number: 0009610622-2018-00305
• Device Sequence Number: 2643243
• Product Code: HSB
• UDI-Device Identifier: 04546540396136
• UDI-Public: 04546540396136
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 17250933S
• Device Lot Number: K060C38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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: Required Intervention
• Patient Age: 22 YR
• Patient Weight: 88