MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1340S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
A broken nail is reported.The primary surgery took place on (b)(6) 2020 at the hospital in (b)(6).The customer reports that the break must have occurred between (b)(6).The patient came in with pain.
Additional Manufacturer Narrative
Correction: please refer to d4 lot number.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.Severe drill marks were found at the entrance of the proximal hole.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect).The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves in both the anterior and posterior web.Starting from the anterior web with an incipient crack at the lateral edge, the breakage progressed through the cross section.Gradually, alongside the anterior web, the posterior web also started getting fatigued and broke ultimately.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user, as the presence of drill marks on the nail indicates towards a user induced cause of failure.The fracture pattern indicates fatigue due to stress evident by line of rest/ waves, the root cause is determined to be user related, predominantly.If any further information is provided, the complaint report will be updated.
Event or Problem Description
A broken nail is reported.The primary surgery took place on (b)(6) 2020 at the hospital in (b)(6).The customer reports that the break must have occurred between 1st august and 1st october.The patient came in with pain.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10972461
• Report Number: 0009610622-2020-00905
• Device Sequence Number: 4329854
• Product Code: HSB
• UDI-Device Identifier: 07613252274278
• UDI-Public: 07613252274278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 02/28/2025
• Device Model Number: 3525-1340S
• Device Catalogue Number: 35251340S
• Device Lot Number: K0429F6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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: 72 YR
• Patient Weight: 78