MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 TARGET DEVICE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Failure to Align (2522)

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

Event Date 03/27/2022

Event Type  malfunction  

Event Description

The customer reported that "when locking the distal screw, it is impossible to chew in the nail hole (dynamic and static).The screw goes under the nail (ancillary checked before).Impossible to lock the nail (screwing under the nail = ineffective)".Additional information received: the 2nd nail was placed and left in place despite the poor positioning of the distal screw.The procedure was delayed by 60 min.

Manufacturer Narrative

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

Manufacturer Narrative

Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned and thus, could not be physically checked in combination with the counterpart [nail] returned.A physical inspection of the targeter used was not possible since only the affected nail was made available for evaluation and thus, limited to details available.The counterpart [nail] returned was tested for functionality resp.Accuracy in alignment with a sample target device.Simulation of pre-operative check performed revealed no discrepancies and accuracy was given as intended.The distal drill passed the drill hole in the nail with no contact.Potentially reduced accuracy in guidance is usually found during functional check [required per ifu].In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check, confirmed by event description ¿¿ancillary checked before¿¿ it was concluded that the event was mainly based in the intra-operative procedure, which is supported by visible signs of damage at the distal bore hole of nail.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited by e.G.Loosening of the nail holding bolt during insertion of the nail; repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended; not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve); no use of drill with centre tip / unfavourable bone contour; drilling without drill guiding sleeve; using blunt or damaged drill; high forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.H3 other text : device disposition unknown.

Event Description

The customer reported that "when locking the distal screw, it is impossible to chew in the nail hole (dynamic and static).The screw goes under the nail (ancillary checked before).Impossible to lock the nail (screwing under the nail = ineffective)".Additional information received: the 2nd nail was placed and left in place despite the poor positioning of the distal screw.The procedure was delayed by 60 min.

• Brand Name: UNKNOWN GAMMA 3 TARGET DEVICE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14192296
• MDR Text Key: 289956371
• Report Number: 0009610622-2022-00149
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• 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