MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0320S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the long gamma nail broke as a result of continuous stress concentration on the nail due to poor reduction.A replacement operation was carried out on (b)(6) 2021.
Additional Manufacturer Narrative
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 received nail is completely broken in the webs of the proximal lag screw hole.Slight drill marks were found at the lateral entrance of the hole on the surface of the distal segment.However, more significant thing to note apart from the drill marks was the sign of overloading.Bearing points of lag screw at the medial edge of the proximal hole showed significant deformation, indicating towards high compressive load.The fracture pattern resembles a fatigue fracture, having equal portions of fatigue zone and instantaneous zone indicating that the breakage initiated in a fatigue manner but quickly broke instantaneously under high compressive loading.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.The instructions for use instructs user that: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.¿ based on the above investigation, it can be said that there is a significantly elevated risk of a non-union due to an inadequate fracture reduction as per the stated event.Also, there is an evident damage of the nail around the proximal hole intraoperatively which may have contributed to mechanical weakening of the construct.The extent of this influence cannot be quantified.Hence the root cause for the breakage of the nail (fatigue fracture due to nonunion induced additional stress and a potential weakening due to mechanical damage) can be attributed to a combination of user and patient related issues, but predominantly patient related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported the long gamma nail broke as a result of continuous stress concentration on the nail due to poor reduction.A replacement operation was carried out on (b)(6), 2021.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM 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: 12045887
• Report Number: 0009610622-2021-00576
• Device Sequence Number: 897761
• Product Code: HSB
• UDI-Device Identifier: 04546540375728
• UDI-Public: 04546540375728
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 04/30/2024
• Device Model Number: 3525-0320S
• Device Catalogue Number: 35250320S
• Device Lot Number: K055442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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