MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600090S

Device Problems Break (1069); Material Separation (1562)

Patient Problems Fall (1848); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

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

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

Investigation summary: received x-ray identified item not at fault.It did not contribute to locking screw breakage.Thus, concomitant item.

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: LAG SCREW, TI GAMMA3® Ø10.5X90MM
• 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: 5441218
• MDR Text Key: 38329561
• Report Number: 0009610622-2016-00060
• 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,other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 30600090S
• Device Lot Number: K03EC6C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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