MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TEFLON TUBE T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0073
Medical Device Problem Codes	Material Fragmentation (1261); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that : "teflon tube which has been damaged with a piece of teflon removed by the guided stem".Update from rep 02/11/2021: the lot number is not available because the product was used so taken out of its original packaging.The lot number is not shown on the device because it is teflon (no marking or engraving).The surgical team told the rep that, the teflon tube "partially disintegrated leaving small pieces in the tissues.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed: the received teflon tube shows severe signs of abrasion and deformation at the distal end.These are most likely to have been induced during insertion and removal, inadequately.The batch record could not be reviewed because the lot number was not available on the returned device and the lot number was not communicated otherwise.A review of the labeling did not indicate any abnormalities.Based on the investigation of the received device and the available information, the root cause of the issue is deemed to be user related.The abrasive distal end with the level of deformation indicates towards a slightly unintended use.Most likely the device interacted with other devices used during the surgery during the insertion and extraction.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that : "teflon tube which has been damaged with a piece of teflon removed by the guided stem".Update from rep 02/11/2021: the lot number is not available because the product was used so taken out of its original packaging.The lot number is not shown on the device because it is teflon (no marking or engraving).The surgical team told the rep that, the teflon tube "partially disintegrated leaving small pieces in the tissues.".

• Brand Name: TEFLON TUBE T2 HUMERUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11498057
• Report Number: 0009610622-2021-00421
• Device Sequence Number: 3858293
• Product Code: LXH
• UDI-Device Identifier: 04546540195869
• UDI-Public: 04546540195869
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 1806-0073
• Device Catalogue Number: 18060073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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