MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø8X260 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18300826S

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 02/15/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned yet as is still remains implanted.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

Doctor who used a t2 standard humeral nail with compression.He cannot know the reason why the advanced compression screw in the nail will back out, making compression feature totally useless.Doctor indicated that he did locking distally and statically first; while when doing the compression, he used x ray control to make sure he did not over or under compress the advanced compression screw.He did mention that the patient has poor bone quality but is it the reason why the compression/apposition failed after post op 3 days.

Manufacturer Narrative

The evaluation revealed the t2 humeral nail and the compression screw to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The items returned were documented as faultless prior to distribution.During investigation no dimensional, functional or manufacturing related issues were found.Within the nail bone residues were found; a bigger bone residue was sticking to the inner nail thread.After the residues were removed an insertion of the compression screw was possible like specified.The provided x-rays show that a compression was performed successfully during the surgery but the compression screw most likely migrated towards proximal so that the compression was no longer given.This migration is most likely the result of the sticking big bone residue, due to postoperatively loads and motion the bone part pressed the screw towards proximal.During intra-operatively compression screw insertion the bone residue most likely caused resistance forces against the insertion that should have been recognized by the surgeon.Because no manufacturer related issue was detected the case is attributed to the user.The ifu includes that the correct implant position has be checked.Review of complaint history and capa databases did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).Due to exceeded occurrence threshold of the risk file line item nc was initiated.Device remains implanted.

Event Description

Doctor who used a t2 standard humeral nail with compression.He cannot know the reason why the advanced compression screw in the nail will back out, making compression feature totally useless.Doctor indicated that he did locking distally and statically first; while when doing the compression, he used x ray control to make sure he did not over or under compress the advanced compression screw.He did mention that the patient has poor bone quality but is it the reason why the compression/apposition failed after post op 3 days.

Manufacturer Narrative

The evaluation revealed the t2 humeral nail and the compression screw to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The items returned were documented as faultless prior to distribution.During investigation no visual, dimensional, functional or manufacturing related issues were found.The compression screw was found fully functional; although bone residues were found within the nail the compression screw could be inserted and screwed to its final position like specified.The bone residues had no influence to the compression screw function.The x-rays and surgeons comments regarding the previous investigation result were evaluated by a health care professional (hcp): ¿the intra-operative x-ray shows that the compression screw is in contact to the proximal lateral/medial placed locking screw; the locking screw is placed in the most distal position within the oblong hole.There is no visible bending of the locking screw, which indicates that the locking screw has no bending stress.The postoperative x-ray (3 days after surgery according to the customer) shows a huge fracture gap.The locking screw has spontaneously moved upwards to its most proximal position within the oblong hole due to unintended spontaneous unscrewing of the compression screw.Usually, a correctly inserted compression screw slightly bends the locking screw when it reaches its final distal position; the elastically bending of the locking screw creates a spring tension effect and locks the thread of the compression screw within the nail.This locking can only occur in case the fracture gap is completely closed and compressed or when the compression screw is firmly tightened against the locking screw in its most distal position to achieve a counter-locking effect.The postoperative x-ray shows that the fracture gap is larger than the maximum compression way of the oblong hole of the nail.After the locking screw reached its distal position within the oblong hole no real bone to bone compression was given because the fracture gap was not fully closed; therefore the locking screw got no spring tension effect to lock the compression screw.The osteoporotic bone did favor this effect.It seems that the surgeon inserted the compression screw until the locking screw was in the most distal position in the oblong hole.But he did not firmly tighten (firmly tighten does not mean ¿overtighten¿) the compression screw against the locking screw and left the compression screw in a loose position allowing for spontaneous loosening of the compression screw.Due to postoperative loads and movement of the arm the compression screw got spontaneously unscrewed towards proximal.¿ because no manufacturer related issue was detected the case is attributed to the user.The ifu includes that the correct implant position has to be checked.Review of complaint history and capa databases did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).Due to exceeded occurrence threshold of the risk file line item nc # was initiated.

Event Description

Doctor who used a t2 standard humeral nail with compression.He cannot know the reason why the advanced compression screw in the nail will back out, making compression feature totally useless.Doctor indicated that he did locking distally and statically first; while when doing the compression, he used x ray control to make sure he did not over or under compress the advanced compression screw.He did mention that the patient has poor bone quality but is it the reason why the compression/apposition failed after post op 3 days.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø8X260 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6394587
• MDR Text Key: 69569120
• Report Number: 0009610622-2017-00073
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K032523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 18300826S
• Device Lot Number: K02E05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention