MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA3 NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on unknown date, patient was implanted with unknown gamma3 short nail for multiple injury and femoral neck fracture.On (b)(6) 2016, surgical treatment again by gamma3 long due to nonunion of the femoral neck fracture.On middle of nov, the patient visited the hospital for pain and it was confirmed that the gamma 3 long was broken.On (b)(6) 2016, it will be treated by unk nail again.

Manufacturer Narrative

The evaluation revealed the broken gamma3 long nail to be the primary product.As no item was returned function and dimension could not be checked.The device history could not be reviewed because a lot-no was not provided.An investigation of the nail itself was not possible because it was not provided.General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced, but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.One requirement for successful nail treatment is a timely bone healing in order to relive the nail over the progressing time of implantation.Another requirement is that the implant must not be damaged during and after insertion.Surface damages reduce the implant¿s durability significantly.A third requirement is that the implant must not be stressed by too high load application e.G.(but not limited to) exceeding weight bearing or overweight or other stresses.Another requirement is that the gamma3 nail must not be used for medial neck fractures.In this case the patient had initially been revised due to non-union of a neck fracture.The kind of neck fracture was not specified ¿ thus, it could not be determined if the used nail was suitable for this indication.It could not be determined whether the nail had been damaged intra-operatively nor if the nail had been placed according to the anatomical requirements respt.If bone fragment reduction was adequate.As no medical records were presented the course of bone healing could not be determined in this case.As the broken long nail had been implanted for more than 6 months and as the patient had suffered from non-union previously an insufficient bone healing could not be excluded for this case.With available information it could not be excluded that the nail most likely broke due to patient conditions.Review of complaint history, capa databases 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.Based on the given information a deficiency of the nail could not be verified.

Event Description

It was reported that on unknown date, patient was implanted with unknown gamma3 short nail for multiple injury and femoral neck fracture.On (b)(6) 2016, surgical treatment again by gamma3 long due to nonunion of the femoral neck fracture.On middle of (b)(6), the patient visited the hospital for pain and it was confirmed that the gamma 3 long was broken.On (b)(6) 2016, it will be treated by unk nail again.

• Brand Name: UNKNOWN LONG GAMMA3 NAIL
• 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: 6149396
• MDR Text Key: 61590634
• Report Number: 0009610622-2016-00603
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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