MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE G-LOK, NO LOOP

Model Number	F
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The product code, product description, and 510k number are not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of oem tag medical.
Event or Problem Description
It was reported that the device broke and unintended material remained in the joint.
Event or Problem Description
It was reported that the device broke and unintended material remained in the joint.
Additional Manufacturer Narrative
The device was not received for evaluation at stryker endoscopy.The device was received at tag for evaluation.Based on the tag service record attached, the reported failure ¿[the surgeon was using the no-loop glok to fixate a distal biceps repair.After passing, the surgeon tested the tension of the tendon and wanted to make sure the button was against the cortex, and the center of the button seemed to break off, with suture pulling back through the tunnel.The piece at the center of the button remained in the patient and could not be retrieved.]¿ was confirmed.According to tag: " yes, g-lok cover (pn 10300co) pulled out of the g-lok body.The item produced to customer with no loop.The llop should be inserted in accordance with ifu 234grst.Tag engineering department assume that during loop insertion process too much force was activated on the cover and it pulled out the g-lok body.Correction: no correction action needs to be performed.Failure mode: g-lok cover missing.Root cause: abnormal use by customer" alleged failure: center of the button broke off manufacture date is not known.

• Brand Name: G-LOK, NO LOOP
• Common Device Name: UNK
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10246569
• Report Number: 0002936485-2020-00260
• Device Sequence Number: 19439455
• Product Code: MBI
• UDI-Device Identifier: 10810190010027
• UDI-Public: 10810190010027
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: F
• Device Catalogue Number: 234-100-000
• Device Lot Number: 18E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 79