MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34300360S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.It was disposed in the hospital.
Event or Problem Description
It was reported that the gamma nail (3130-2170s) was inserted about one year before.The distal of the nail was broken and it was revised to gamma long nail at (b)(6) 2019.At revision surgery, it was 130° nail to detain, but only the 125° nail was prepared.The reason of this event was miscommunication of surgeon and sr.Surgery stopped about 90 min with anesthesia on the patient to wait for the arrival of the implant.After that, the surgery was finished with no problem.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on available information, possible cause of failure could be attributed to patient related issue (non-union, high load, heavy weight) which led to the material damage.The implant broke after around 1 year since the primary surgery, therefore a non-union is very likely.The device inspection was not possible as the product was not returned for investigation.No indications of material, manufacturing or design related problems were found during the investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The ifu includes that obesity, traumatic overloads and non-unions can lead to implant failures like breakages.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the gamma nail (3130-2170s) was inserted about one year before.The distal of the nail was broken and it was revised to gamma long nail at (b)(6) 2019.At revision surgery, it was 130° nail to detain, but only the 125° nail was prepared.The reason of this event was miss communication of surgeon and sr.Surgery stopped about 90 min with anesthesia on the patient to wait for the arrival of the implant.After that, the surgery was finished with no problem.Additional information received: "the correct product # was 3430-0360s".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM X 130°
• 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: 8414661
• Report Number: 0009610622-2019-00107
• Device Sequence Number: 1612504
• Product Code: HSB
• UDI-Device Identifier: 04546540375148
• UDI-Public: 04546540375148
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 34300360S
• Device Lot Number: K02CA17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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