MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 PROX. HUM.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 18062035

Device Problem Material Distortion (2977)

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

Event Date 04/27/2015

Event Type  malfunction  

Event Description

It is reported by the nurse of the hospital, that the device is distorted.According to the statement of 2 surgeons, it was warped.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation revealed the targeting arm t2 prox.Hum.To be the subject product.No further associated products were reported.Review of the inspection records revealed no discrepancies.A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed that function was given in full on the devices at the stage of delivery.Evaluation did not reveal any discrepancies in material or manufacturing.As the targeting arm had been in use for approximately 10 years we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.The pre-operative test performed revealed the targeting accuracy being as intended.The drill could be passed through all drill holes while checking the possible locking options without contact to the nail although a small crack was found in the cfr-material.The alleged warp / misdrilling could thus neither be verified nor reproduced.Potential causes of misaligned drilling are various: deflection and / or twisting of the nail during insertion in case the user applied undue force for insertion.Loosening of the connection between nail / nail holding screw (will lead to potential misalignment of nail and drill).No use of drill with center tip / unfavorable 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.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 it was concluded that the alleged event was mainly based in the intra-operative procedure.Based on the above facts it can be ascertained that the event was not caused by any deficiency of the device.Although a real root cause could not be determined the alleged event was most likely caused due to a suboptimal intra-operative procedure.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

It is reported by the nurse of the hospital, that the device is distorted.According to the statement of 2 surgeons it was warped.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4770461
• MDR Text Key: 5947851
• Report Number: 0009610622-2015-00241
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18062035
• Device Lot Number: KP257295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2005
• 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