MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0163
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "staff was trying to affix the t2 humeral nail to targeter with nail holding bolt.Bolt would not thread into nail.Upon inspection we noticed threads on the nail holding bolt are broken." additionally reported: event occurred intra-operatively.Surgery was completed successfully with no delay.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Correction: refer to d10/h3, h6-results code.The reported event could be confirmed.The device inspection revealed the following: the received nail holding screw, humerus t2 humerus 10 mm shows extensive usage from long period.The breakage indicates that during insertion a chisel or sharp object was used on the threads of nhs which is clear sign of an abnormal use.A review of the device history for the returned lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The failure was caused by abnormal handling by user.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "staff was trying to affix the t2 humeral nail to targeter with nail holding bolt.Bolt would not thread into nail.Upon inspection we noticed threads on the nail holding bolt are broken.".Additionally reported: event occurred intra-operatively.Surgery was completed successfully with no delay.No further information will be released by the hospital or surgeon.

• Brand Name: NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9488556
• Report Number: 0009610622-2019-00972
• Device Sequence Number: 1542325
• Product Code: LXH
• UDI-Device Identifier: 04546540196095
• UDI-Public: 04546540196095
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1806-0163
• Device Catalogue Number: 18060163
• Device Lot Number: K884162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1