MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35251340S

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital policy.

Event Description

It was reported that patient had a gamma nail implanted in their hip and patient then fell post operatively and damaged their hip further.Surgeon did a removal of long gamma nail due to post op fall - no hardware was broke however damage was done to patient's hip as a result of the fall requiring another surgery and surgeon removed the gamma nail and replaced with a total hip utilizing the restoration modular system.

Manufacturer Narrative

Product inquiry stated the reported long nail kit r1.5, ti, left gamma3® ø11x340mm x 125° to be the primary product.The other implants reported were considered as concomitant products as they did not contribute to the event reported.Review of the device history records revealed no discrepancies.The long nail kit was documented as faultless prior to distribution.No material, design or manufacturing related issues were found.A physical examination of the items could not be carried out as the devices were not returned to stryker (b)(4) (hospital policy).However, referring to the event description no product deficiency was subject of the event reported.In this case the cause for the implant removal was based on a fall of the patient.After approximately 4 weeks of implantation the patient fell and damaged her hip.The long nail kit was removed and replaced by a total hip.¿no hardware was broke.However damage was done to patient's hip as a result of the fall requiring another surgery.¿ the use of a total hip arthroplasty as revision implant leads furthermore to the assumption of a reduced bone quality.General aspects: implant removal may be necessary although no product deficiency is given.Possible reasons could be (but not limited to) non-union, cut-out, motor loss (potentially resulting from a fall) or multi-fractural-situation.Such harms do not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition etc.With given information it can be concluded that the revision had to be carried out due a damaged hip.The reported information did not allege any deficiency in the identity, quality, reliability, safety, effectiveness or performance of the device.From technical point of view a further statement was not possible.With available information the cause of the event was most likely based on the patient¿s condition (fall).A deficiency of the product in question could not be verified.In case the products and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

It was reported that patient had a gamma nail implanted in their hip and patient then fell post operatively and damaged their hip further.Surgeon did a removal of long gamma nail due to post op fall - no hardware was broke; however, damage was done to patient's hip as a result of the fall requiring another surgery and surgeon removed the gamma nail and replaced with a total hip utilizing the restoration modular system.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5346422
• MDR Text Key: 35161238
• Report Number: 0009610622-2016-00002
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 35251340S
• Device Lot Number: K0593E5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 93 YR