MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200100

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that after successful implantation of the lag screw, targeting arm still felt loose to the surgeon.Surgeon attempted to lock distally in static mode, but drill bit entered patient anterior to the nail.After attempting several times to target the drill bit through the nail, the surgeon removed the targeting arm and used perfect circular to lock distally.Nail holding screw was checked for tightness prior to removing arm.Twenty (20) minute delay in surgery.

Manufacturer Narrative

The evaluation revealed the target device to be the primary product.An investigation and a review of the dhr were not possible due to missing product and missing lot code/serial number.The root cause of the misdrilling could not be determined.Reasons for misaligned drilling and misaligned distal locking screws are various.Potential miss-targeting can also be caused but is not limited by e.G.: no fully tightened nail holding screw, bending forces to the drill / drill sleeve during drilling, drill sleeve has no contact to the bone surface, usage of worn drills.Regarding misdrilling the operative technique has already been modified by ecn (b)(4).Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure.Review of complaint history, capa databases, risk analysis and labelling 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.

Event Description

It was reported that after successful implantation of the lag screw, targeting arm still felt loose to the surgeon.Surgeon attempted to lock distally in static mode, but drill bit entered patient anterior to the nail.After attempting several times to target the drill bit through the nail, the surgeon removed the targeting arm and used perfect circular to lock distally.Nail holding screw was checked for tightness prior to removing arm.20 minute delay in surgery.

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• 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: 6752227
• MDR Text Key: 81410254
• Report Number: 0009610622-2017-00237
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123401
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other