MAUDE Adverse Event Report: STRYKER GMBH HUMERAL NAIL T2 HUMERUS Ø7X270 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1830-0727S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "primary procedure, left humeral nail.It was reported that after the locking screw was implanted at the distal end of the nail, the surgeon back-slapped the construct to compress a fracture.The distal end of the nail broke at the junction with the locking screw.The screw was removed and another locking screw was implanted above the previous implant site.Procedure was completed successfully with a delay of approximately 1-2 minutes.Additional info received on 03/09/2021: distal locking screw did not break, only distal end of nail.Distal locking screw was removed and replaced with another locking screw that locked the nail in the most proximal hole of the distal locking options in.The broken tip as well as the rest of the nail and locking screws remains in patient to fix their mid shaft humerus fracture.The small universal extraction rod that is dedicated to the t2 humeral system was used to back-slap.The screw was not broken, the tip of the nail at the screw hole junction was.".
Additional Manufacturer Narrative
The reported event could be confirmed with the help of x-rays provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Avoid surface damage of implants.Discard all damaged or mishandled implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.¿ formal medical opinion was sought from an experienced independent medical expert and he confirmed that it is an off-label use and not as per the operative technique.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to an off-label use i.E.Hitting the nail to reduce the fracture.The optech states: ¿the reduction rod (1806-0363) may be used as a fracture reduction tool to facilitate guide wire insertion across the fracture site.The nail should be advanced with manual pressure.Aggressive use of the slotted hammer can result in additional fractures.¿ if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "primary procedure, left humeral nail.It was reported that after the locking screw was implanted at the distal end of the nail, the surgeon back-slapped the construct to compress a fracture.The distal end of the nail broke at the junction with the locking screw.The screw was removed and another locking screw was implanted above the previous implant site.Procedure was completed successfully with a delay of approximately 1-2 minutes.Additional info received on 03/09/2021 distal locking screw did not break, only distal end of nail.Distal locking screw was removed and replaced with another locking screw that locked the nail in the most proximal hole of the distal locking options in.The broken tip as well as the rest of the nail and locking screws remains in patient to fix their mid shaft humerus fracture.The small universal extraction rod that is dedicated to the t2 humeral system was used to back-slap.The screw was not broken, the tip of the nail at the screw hole junction was.".
Additional Manufacturer Narrative
New information indicates that this incident is linked to fda maude report mw5116042.Corrections in section d4 the legal manufacturer.The reported event that humeral nail t2 humerus ø7x270 mm was alleged of issue ¿implant - breakage intra-operative¿ could be confirmed with the help of x-rays provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Avoid surface damage of implants.Discard all damaged or mishandled implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.¿ formal medical opinion was sought from an experienced independent medical expert and he confirmed that it is an off-label use and not as per the operative technique.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to an off-label use i.E.Hitting the nail to reduce the fracture.The optech states: ¿the reduction rod (1806-0363) may be used as a fracture reduction tool to facilitate guide wire insertion across the fracture site.The nail should be advanced with manual pressure.Aggressive use of the slotted hammer can result in additional fractures.¿ if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
New information indicates that this incident is linked to fda maude report mw5116042.Reported on 03/05/2021: "primary procedure, left humeral nail.It was reported that after the locking screw was implanted at the distal end of the nail, the surgeon back-slapped the construct to compress a fracture.The distal end of the nail broke at the junction with the locking screw.The screw was removed and another locking screw was implanted above the previous implant site.Procedure was completed successfully with a delay of approximately 1-2 minutes.Additional info received on 03/09/2021 1) distal locking screw did not break, only distal end of nail.2) distal locking screw was removed and replaced with another locking screw that locked the nail in the most proximal hole of the distal locking options in.The broken tip as well as the rest of the nail and locking screws remains in patient to fix their mid shaft humerus fracture.4)the small universal extraction rod that is dedicated to the t2 humeral system was used to back-slap.5)the screw was not broken, the tip of the nail at the screw hole junction was.".

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X270 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11604256
• Report Number: 0009610622-2021-00436
• Device Sequence Number: 17043936
• Product Code: HSB
• UDI-Device Identifier: 04546540201331
• UDI-Public: 04546540201331
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032523
• 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,Followup
• Report Date (Section B): 10/17/2024

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: 07/31/2024
• Device Model Number: 1830-0727S
• Device Catalogue Number: 18300727S
• Device Lot Number: K0955A7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 09/12/2024
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/22/2021; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male