MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3LAG SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Migration (4003)

Patient Problems Perforation (2001); Hip Fracture (2349)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by customer.

Event Description

"the stryker sales representative reported that a patient who had been implanted with a gamma nail and a lag screw was revised.It was noticed post operatively that the nail was fine, but the lag screw had perforated the femoral head and migrated towards the pelvis.The healing process had finished when the lag screw went into the bone.There was no damage to arteries.The stryker sales representative noticed bony in growth between the explanted lag and set screws.The sales representative tried to remove the set screw from the explanted nail after the case but it had threaded onto the nail and was stuck".

Manufacturer Narrative

The reported event could be confirmed, since the provided details showed screw migration.The available images were forwarded to a health care professional, which confirmed the migration as well but cannot be further specified based on existing one plane view.No further additions.Furthermore, a bony ingrowth between lag screw and set screw was reported, which could be a hint that the positioning of set screw was not as intended from the beginning on.Therefore, it was forwarded for statement as well and from clinical point of view following was stated [excerpts]: ¿in the pictures you cannot judge that in my opinion.If they describe it this way, in my opinion the set screw cannot have set properly in the lag screw¿.The basics of the gamma-system are the interaction of nail set including a set screw and lag screw in the proximal area.The intention is to allow the fracture site to subside [if the fracture gap is too big] in order to support bone union.This requires motion in a relative rigid construction and is solved by lateralization of the lag screw.The set screw ¿ as part of the nail kit - is designed to fit into one of the four grooves of the shaft of the lag screw with ascending shapes at both medial and lateral.This prevents both rotation and complete migration of the lag screw but allows sliding in a limited and defined range.Known from previous cases it¿s rather related to a not properly seated set screw [set screw had not been reached the ground of the groove resp.Was unscrewed for more than ¼ of a turn resulting in exceeded motion of the lag screw towards medial].More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Therefore, from technical point of view in this case a statement is impossible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.With available information a deficiency of the devices in question was not verified.

Event Description

"the stryker sales representative reported that a patient who had been implanted with a gamma nail and a lag screw was revised.It was noticed post operatively that the nail was fine, but the lag screw had perforated the femoral head and migrated towards the pelvis.The healing process had finished when the lag screw went into the bone.There was no damage to arteries.The stryker sales representative noticed bony in growth between the explanted lag and set screws.The sales representative tried to remove the set screw from the explanted nail after the case but it had threaded onto the nail and was stuck".

• Brand Name: UNKNOWN GAMMA 3LAG SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11679737
• MDR Text Key: 245845871
• Report Number: 0008031020-2021-00167
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention