MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by surgeon of a patient that he was seeing at the time who came in with a broken trochanteric gamma nail.The patient presented to the surgeons office complaining of hip pain after admitting to a fall at home.

Manufacturer Narrative

The evaluation revealed the broken trochanteric nail kit, ti gamma3® ø11x180mm x 125° to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.An investigation of the broken nail was not possible because it was not available.Therefore, the evaluation is based only on the given information.The customer reported that the patient fell at home and visited the surgeon due to hip pain; an x-ray evaluation revealed that the implanted nail was broken.Most likely the nail got broken caused by a single overload due to the patient¿s fall.The review of the dhr shows no manufacturing or material issues, therefore the case is attributed to the patient.Overloads due to fall can lead to implant breakages and are listed as warning in the ifu.A more precise evaluation was not possible due to missing product and missing information.Review of complaint history, capa databases, labelling 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 by surgeon of a patient that he was seeing at the time who came in with a broken trochanteric gamma nail.The patient presented to the surgeons office complaining of hip pain after admitting to a fall at home.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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: 6613844
• MDR Text Key: 76719702
• Report Number: 0009610622-2017-00174
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 31251180S
• Device Lot Number: K0424AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• 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
• Patient Age: 36 YR
• Patient Weight: 57