MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3® Ø10.5X110MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 40600110S

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The nurse reported the following event: the reference of the product on the packaging is different from the one written on the product record label.The packaging is not available for evaluation as it has been discarded, she confirms that the reference written on the cardboard box is different from the one on the patient record label.

Manufacturer Narrative

Product inquiry states the lag screw, stst gamma3® ø10.5x120mm to be the subject product.No associated products were reported.A review of the dhr revealed no deviations and the device was documented as faultless prior to distribution.A physical evaluation could not be performed as the packaging [labelling] in question was not returned for investigation as it was already discarded by the hospital and the nail is still implanted.A detailed review of the corresponding label copy sheet of the lot code in question revealed no discrepancies.There is no evidence like a photo which confirms the reported case.Based on the information given an exact root cause could not be determined.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future we reserve the right to reopen the case and to change the root cause.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

The nurse reported the following event: the reference of the product on the packaging is different from the one written on the product record label.The packaging is not available for evaluation as it has been discarded, she confirms that the reference written on the cardboard box is different from the one on the patient record label.

• Brand Name: LAG SCREW, STST GAMMA3® Ø10.5X110MM
• 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: 5912493
• MDR Text Key: 54210397
• Report Number: 0009610622-2016-00420
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043431
• 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: 08/04/2016

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 40600110S
• Device Lot Number: K0B72C2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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): Other