MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X330 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-1133S
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Customer reported to our sales rep difficulties when screwing the nail onto the tibial target device.Immediate stop of screwing and checking of the thread - abnormal presence of filings/debris in the nail thread.Additionally reported: the procedure was an osteosynthesis of a leg fracture.The event happened before the procedure : while the material was being prepared: the incident occurred, so they took another nail to proceed.No patient involvement because it happened just before the surgery, they did not tried to install the defective nail.
Event or Problem Description
Customer reported to our sales rep difficulties when screwing the nail onto the tibial target device.Immediate stop of screwing and checking of the thread - abnormal presence of filings/debris in the nail thread.Additionally reported: the procedure was an osteosynthesis of a leg fracture the event happened before the procedure : while the material was being prepared : the incident occurred, so they took another nail to proceed no patient involvement because it happened just before the surgery, they did not tried to install the defective nail.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the received nail first two threads deformed, and metal chips received.The pattern shows that oblique / incorrect positioning of nail and nail adapter during attempt(s) to screw in the nail holding screw by excessive force has led to cross-threading and complete peeling of the thread tips of the first two windings, which were in the form of metal chips.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation, the root cause was attributed to a user related issue.The failure was caused due to incorrect positioning of nail and nail holding screw while screwing in.Ultimately, due to misalignment, excessive force was then applied leading to cross threading and subsequent material shear off.If any further information is provided, the complaint report will be updated.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X330 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9395264
• Report Number: 0009610622-2019-00947
• Device Sequence Number: 19481339
• Product Code: HSB
• UDI-Device Identifier: 04546540198037
• UDI-Public: 04546540198037
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003018
• 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): 01/27/2020

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 Expiration Date: 01/31/2024
• Device Model Number: 1822-1133S
• Device Catalogue Number: 18221133S
• Device Lot Number: K080C95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR