MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35250340S

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

It was reported that on the unknown date, a gamma nail was implanted.After about 6 months later, the gamma nail was broken around lag screw area.(b)(6) 2017, revision performed for the broken nail using the extraction.Removed the broken gamma successfully, however it couldn't remove the broken gamma and the extracted device out of patient body.The broken gamma nail was extracted by the extracted device out of patient body successfully.But after removing, it couldn't separate the broken gamma and the extracted device.

Manufacturer Narrative

The evaluation revealed the broken nail and extraction adapter to be the primary products.The customer complained two events: a) the broken gamma3 nail.Regarding broken nail: no deviations were found during review of the manufacturing and inspection documents (dhr).During investigation no material, dimensional, visual or manufacturing related issues were found.The reported event could be confirmed; the nail was broken within its proximal hole for the lag screw.The breakage lines and breakage surfaces indicate that the nail broke from lateral towards medial step by step in a fatigue fracture, beginning at the anterior bridge.Drilling marks within the nail hole at the anterior bridge did most likely weakened the nail hole and favored the nail breakage.The customer reported that the nail was broken after approx.6 months of implantation.Based on the given information the case is attributed to the patient (delayed healing).Review of complaint history, capa databases, labeling and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

It was reported that on the unknown date, a gamma nail was implanted.After about 6 months later, the gamma nail was broken around lag screw area.On (b)(6) 2017, revision performed for the broken nail using the extraction.Removed the broken gamma successfully, however it couldn't remove the broken gamma and the extracted device out of patient body.The broken gamma nail was extracted by the extracted device out of patient body successfully.But after removing, it couldn't separate the broken gamma and the extracted device.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X340MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6660282
• MDR Text Key: 78174536
• Report Number: 0009610622-2017-00196
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 35250340S
• Device Lot Number: K05F382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention