MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35250280S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2018
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 primary surgery with gamma nail was performed on (b)(6) 2017.About 10 months later, the nail breakage due to false joint was observed then revision surgery was performed on (b)(6) 2018.
Event or Problem Description
The primary surgery with gamma nail was performed on (b)(6) 2017.About 10 months later, the nail breakage due to false joint was observed then revision surgery was performed on (b)(6) 2018.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, left gamma3® ø10x280mm x 125° was alleged of 'revision' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the damage of the implant during the drilling by the user, which caused the weakening of the implant.The device inspection shows traces of drilling on the hole of the nail, proving that a misdrilling occured, which most likely weakened the implant.The nail should have been discarded and replaced by a new one inter-operatively.Furthermore, the non-union of the bone 10 months after implantation must have over-stressed the implant which must have accelerated its breakage.The device inspection revealed the following: the device inspection shows traces of drilling on the hole of the nail.Proving that a misdrilling occured, which most likely weakened the implant.The breakage areas show one shiny surface on one side of the bridge, which confirms that the device broke first at that level, and had the two parts rub onto each other ( thus polishing the metal).The second part of the bridge shows a clean break, showing that the device finally gave it there.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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM 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
• MDR Report Key: 7875038
• Report Number: 0009610622-2018-01047
• Device Sequence Number: 13965390
• Product Code: HSB
• UDI-Device Identifier: 04546540375704
• UDI-Public: 04546540375704
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 06/30/2018
• Device Catalogue Number: 35250280S
• Device Lot Number: K035BA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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