MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 11X400 GAMMA NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Necrosis (1971); Injury (2348)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.

Event Description

This report is for the first surgery on (b)(6) 2020.Nail removal, left femur.Reason for nail removal is avascular necrosis, there were no allegations against the implants prior to removal.However, during removal only the proximal part of the nail came out.Surgeon reported the nail must have already been broken proximal to the lag screw while in situ.The remainder of the nail was left in the patient and removed in a second procedure the next day as the needed universal extraction kit was not available in the hospital.The rep confirmed no further information is available.

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 gamma nail was found to be broken around the proximal region at the point of lag screw insertion hole.It was found to be a fatigue fracture.The device history record could not be reviewed because the proximal part (consisting product info.) was not returned, and the lot number was not communicated.Based on the provided x-rays, a clinical statement was requested for the evaluation of the provided medical data.The following statements were provided: ¿the surgeon treated well (a further reposition of the remaining fracture gap, e.G.With a k-wire, would have been possible, though).The head slipped of the neck and shows no typical signs of avascular necrosis.There are some signs showing osteopenic bone structure, it can be assumed with a 92 yr old female with limited mobilization that she has at least osteopenic bone.The x-rays of (b)(6) 2020 suggest that the nail is already broken.Probably due to the additional load resulting from the subcapital fracture there is no avn, i would say.The reason is the additional load after the subcapital fracture occurred (or did not heal, if it already existed initially and was only undisplaced).¿ a review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue (patient factors issue).The failure was caused by additional load after the subcapital fracture occurred (or did not heal, if it already existed initially and was only undisplaced) and moreover ifu also states that this 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.If remaining part of the device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

This report is for the first surgery on (b)(6) 2020.Nail removal, left femur.Reason for nail removal is avascular necrosis, there were no allegations against the implants prior to removal.However, during removal only the proximal part of the nail came out.Surgeon reported the nail must have already been broken proximal to the lag screw while in situ.The remainder of the nail was left in the patient and removed in a second procedure the next day as the needed universal extraction kit was not available in the hospital.The rep confirmed no further information is available.

• Brand Name: UNKNOWN 11X400 GAMMA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10284868
• MDR Text Key: 199922129
• Report Number: 0009610622-2020-00324
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR