MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31201180S

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Death (1802)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported that patient was revised due to delayed union.Patient was implanted with stryker nail (b)(6) 2015, explanted(b)(6) 2016 and implanted with non-stryker hip.The subject was implanted with a spii total hip replacement from the firma link.Patient passed away 5 days after on (b)(6) 2016.

Manufacturer Narrative

The reported issue was evaluated by a hcp to define whether the product did contribute to the event.The hcp defined the case as sae, according to procedure (b)(4) ¿clinical investigation - adverse event reporting¿ sae means serious adverse event and is non-device-related.Therefore a relationship between the reported death of the patient and the reported implant can be excluded.Because the reported event is not device related it is not a complaint according to procedure (b)(4) ¿stryker corporation quality and regulatory master glossary¿; according to the procedure a complaint is defined as ¿any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a stryker device after it is released for distribution by a manufacturing site.¿.

Event Description

It was reported that patient was revised due to delayed union.Patient was implanted with stryker nail (b)(6) 2015, explanted (b)(6) 2016 and implanted with non-stryker hip.The subject was implanted with a spii total hip replacement from the firma link.Patient passed away 5 days after on (b)(6) 2016.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°
• 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: 6119490
• MDR Text Key: 60621940
• Report Number: 0009610622-2016-00513
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 31201180S
• Device Lot Number: K078772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Weight: 56