MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250340S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that patient stumbled on (b)(6) 2018 behind her walker and fell on her couch.She had sustained a "sub pertrochanteric fracture".An elongated gamma3 nail was placed in an (b)(6) female patient at (b)(6) 2018, position: left proximal femur.Post surgical protocol: mobilization in reliance on pain: patient used a walker for movement.After the initial surgery the patient could start carefully load her injured leg again following normal protocol.Patient didn¿t fall nor jump nor did anything else that compromised her health and recovery.In the first week of (b)(6) she developed pain in her left hip which persisted already a few days.On the (b)(6) an x-ray was taken.The nail seemed to be broken.That day or nurse, got in touch to investigate what instruments where available for extracting the broken nail and the revision or was planned on the (b)(6).
Additional Manufacturer Narrative
Deficiency in material or manufacturing was not found.Dimensional examination revealed no deviations in the relevant undamaged areas.The affected item was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.The received nail was completely broken in the webs of the proximal drill hole for the lag screw.Mechanical damage (drill marks) at the lateral edge inside the proximal drill hole of the anterior web - had been caused by the contact with a deviated step drill.Such damage may cause additional notch effects.In this case the drill marks had initially reached into the level of the incipient crack in the anterior web, creating the starting point of the nail breakage.Damage found at the thread of the locking screw such as considerable friction signs resp.Bearing points indicate high axial load application as well; which is considered as patient behaviour related.The thread flanks of the locking screw are significantly flattened.The appearance identified a high axial load application to the implants.Axial load may have contributed to the progress of the incipient crack at lateral.Another prerequisite for a successful supply is undisturbed, normal bone healing.In this case the revision surgery on 16.04.2019 with a gamma3® nail could be a hint to insufficient bone healing after an implantation period of 16 weeks.Regarding technical aspects in this case the nail broke in fatigue manner after an implantation period of 16 weeks.During this period the implant had to absorb / transfer the whole loading because not relieved by increasing bone healing.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting fatigue of material.If the loads are above a certain threshold (microscopic) cracks will begin to form on the surface.Intra-operative material damage at the lateral edge of the proximal drill hole most likely contributed to the origination of an incipient crack.Omitting pre-drilling for the placement of the k-wire may have contributed to deflection of the stepdrill (due to bone contour) during preparation for the canal for the lag screw.Intra-operative implant damage and postoperative loads are listed as adverse effects in the ifu.Evaluation revealed that the present breakage of the nail was most likely caused by intra-operative material damage contributed by high axial load application.
Event or Problem Description
It was reported that patient stumbled on (b)(6) 2018 behind her walker and fell on her couch.She had sustained a "sub pertrochanter fracture".An elongated gamma3 nail was placed in an 71-year-old female patient at (b)(6) 2018, position: left proximal femur.Post surgical protocol: mobilization in reliance on pain: patient used a walker for movement.After the initial surgery the patient could start carefully load her injured leg again following normal protocol patient didn¿t fall nor jump nor did anything else that compromised her health and recovery.In the first week of april she developed pain in her left hip which persisted already a few days.On the 9th an x-ray was taken.The nail seemed to be broken.That day or nurse, got in touch to investigate what instruments where available for extracting the broken nail and the revision or was planned on the (b)(6) april.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8597225
• Report Number: 0009610622-2019-00243
• Device Sequence Number: 2180817
• Product Code: HSB
• UDI-Device Identifier: 07613153313496
• UDI-Public: 07613153313496
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 33250340S
• Device Lot Number: K05E004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 67