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

Catalog Number 13200111

Device Problem Component Falling (1105)

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

Event Date 03/25/2017

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

During gamma case, surgeon decided to change from standard gamma jig to gamma plus jig given larger anatomy, when scrub nurse removed target device sleeve a small part of the jig material fell out and on closer inspection, damage to the distal grooves on the standard gamma targeting device was observed.Targeting sleeve was then connected to the gamma plus jig & procedure commenced as planned without delay.

Manufacturer Narrative

Evaluation revealed the target device as primary product.No associated products were reported.Deviations in the inspection documents were not found.A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery.Although partly damaged the functional test revealed function was given as intended.The damage found is known but not as device related but rather related to inadequate handling (rough handling) in an intra-operational procedure or during cleaning.Appearance and evidences of the breakage surface as well as the absence of plastic deformation indicate that a part of the peg broke in a brittle manner due to overload.This would have been noticed during pre-operative check as the broken off peg is clear visible.The event was not device related.Investigation revealed evidence that the partly broken off peg was caused by inappropriate rough handling at user site.An internal test (reproduction of the breakage of the peg) revealed that the breakage could be reproduced in case the targeting sleeve (speedlock sleeve) was not inserted to its dead stop position and high torsion load was applied to the targeting sleeve respective speedlock sleeve causing the breakage of the peg at the connection area.In order to avoid above damage the design of the affected area has already been improved by ecn.The brochure instructions for cleaning, sterilization, inspection and maintenance shows several examples of damages and recommends removing of such damaged products.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 alleged issue was addressed adequately.There are no actions in place related to the reported event for the subject product.Investigation revealed no non-conformity, therefore no ncr was initiated.A review of the labeling did not indicate any abnormalities.

Event Description

During gamma case, surgeon decided to change from standard gamma jig to gamma plus jig given larger anatomy, when scrub nurse removed target device sleeve a small part of the jig material fell out & on closer inspection, damage to the distal grooves on the standard gamma targeting device was observed.Targeting sleeve was then connected to the gamma plus jig & procedure commenced as planned without delay.

• Brand Name: TARGET DEVICE GAMMA3®
• 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: 6511789
• MDR Text Key: 73563493
• Report Number: 0009610622-2017-00117
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

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: 13200111
• Device Lot Number: KME908602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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