MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE; INSTRUMENT

Catalog Number UNK_KIE

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw" update 08/02/2021 the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.

Event Description

The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw".Update 08/02/2021: the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.

Manufacturer Narrative

The risk assessment of the event, performed during the complaint investigation, concluded on an actual severity of harm of s2, which shall be filed as malfunction as per our procedure.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Due to unknown lot code a dhr review was impossible.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.The file will be closed formally in accordance to our procedures.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: UNKNOWN TARGET DEVICE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12369748
• MDR Text Key: 268207120
• Report Number: 0009610622-2021-00667
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 12/22/2021
• 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): Required Intervention