MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM; IMPLANT

Catalog Number 18965035S

Device Problems Break (1069); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Fall (1848); Pain (1994); Impaired Healing (2378); Ambulation Difficulties (2544)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown gamma pin.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

It was reported that patient had a gamma nail implanted 2 years ago in their left leg.Patient stated that after 6 months, their surgical site was less than 20% healed and that the gamma screw had separated and the pin at the bottom broke.Not revised, started causing pain approximately 2 to 3 months ago and patient wants to know if any of the devices were recalled.Patient additionally reported that she kept falling and having trouble with it.Felt like it was coming out the side of her thigh.Has a funny gait, does not walk right.For a while it was not hurting.Staring a month ago, it started to burn again.

Manufacturer Narrative

As no item was returned no physical examination could be carried out.As no lot-no was provided manufacturing documents could not be reviewed.The rmf had considered potential implant breakage.The threshold was not exceeded.Investigation revealed no non-conformity; therefore no new capa was initiated.General aspects: the broken implant is a temporary implant which inevitably will be subject of a fatigue fracture if the 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.If fracture healing is insufficient mechanical damage of a load-bearing or load-sharing device is more likely.Generally the risk of a breakage will increase with the increase of load cycles and load level.Breakage of distal locking screws in general has been experienced but does not present an unanticipated event in itself.Depending on load application ¿ e.G.The patient¿s weight and post-implant activity ¿ 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 a locking screw breakage can rather be classified as anticipated (ref to ifu).A successful treatment with a temporary implant requires sufficient bone healing during the implantation period and adequate load application.Technical aspects: as to outstanding product the kind of locking screw breakage could not be determined.Possible damages on the implant caused after distribution or intra-operatively, could not be verified.Useable pictures revealed intact implants in follow-up examination on may 29, 2014 (on cd) where an a-p-view, as part of a ct-scan, showed the hip with the intramedullary nail and its accessories, approx.6 months after initial surgery.After further approx.18 months, which present a long period of implantation, the locking screw was broken.This was visible on received paper copies of poor quality, dated november 05, 2015.Due to poor quality it was not possible to determine the development of bone healing.In this case the locking screw had broken after an implantation period of approx.23 months.During this period the implant had to absorb / transfer the whole loading because not relieved ¿ at least in the first 6 months ¿ by increasing bone healing.The follow-up report on may 29, 2014 stated ¿incompletely united basicervical left femoral neck fracture.¿ minimal partial fracture healing ¿ estimated to represent less than 20% fracture union.¿.Ct findings suggest less than 20% fracture union with the remaining 80% chronically ununited¿ it is very likely that during the following period and due to usual / daily motion the implant was repeatedly loaded in back and forth direction (cyclic loading) which typically contributes to the origin of an incipient crack.Every additional load application may contribute to the progress of an existing crack.A history of fall was repeatedly mentioned in the follow-up report.Stumbling and / or falling increases the risk of initial cracks resp.The progress of a crack and may have contributed to complete separation of the locking screw.In question.The ifu refers to complications caused by e.G.Increased loading, delayed union and falls or accidents.The patient¿s weight ((b)(6)) may also have contributed to screw breakage.The ifu points out that the risk of post-operative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations.Medical aspects: a medical review was not reasonable because there were no suitable medical records available (only poor paper copies) for the period after may 2014 where the screw appeared to be unbroken.Once suitable medical records have been provided a hcp will be commissioned for medical review.With given information it could not be determined if sufficient bone healing had developed sufficiently prior to implant breakage.Summarizing above information the implant most likely broke due to overload.Overload may have been caused by patient¿s load application possibly in conjunction with impaired bone healing and contributed by repeated falls.Potential intra-operative damage would decrease the locking screw¿s durability, additionally.With available information, a deficiency of the locking screw could not be verified.In case relevant information resp.The part becomes available (after revision) we reserve the right to update the investigation and to change the root cause.

Event Description

It was reported that patient had a gamma nail implanted 2 years ago in their left leg.Patient stated that after 6 months, their surgical site was less than 20% healed and that the gamma screw had separated and the pin at the bottom broke.Not revised, started causing pain approximately 2 to 3 months ago and patient wants to know if any of the devices were recalled.Patient additionally reported that she kept falling and having trouble with it.Felt like it was coming out the side of her thigh.Has a funny gait, does not walk right.For a while it was not hurting.Staring a month ago, it started to burn again.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM
• Type of Device: IMPLANT
• 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: 5368584
• MDR Text Key: 36027653
• Report Number: 0009610622-2016-00014
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965035S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• 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: 74 YR
• Patient Weight: 64