MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM; PLATE, FIXATION, BONE

Catalog Number	627204
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed.The ethicon pds cord is a resorbable suture thread, therefore the use of this product with the stryker axsos humeral plate is not recommended.The operative technique instructs, that the use of resorbable suture threads is considered an off-label use with axsos humeral plate.The microscopy analysis of the device revealed slightly chipped edge of the material at the level of one of the suture holes.Further examination showed that the area appears to be shinier, which indicates that the originally anodized surface in this area was compromised after the device left stryker control.The root cause of the chipped material is likely due to the manipulation of the plate during one of the multiple revision surgeries.The subject plate was used for the primary surgery and 3 additional medical interventions during which the plate was not removed from the patient.In all surgeries, the plate remained fixated to the bone, which indicates that in order to reattach the suture threads, a sharp / pointy device had been used.This device most likely has caused the damage of the plate material and in addition may also have contributed to the ripping of the arthrex suture threads.It is important to state that for the primary surgery and the first revision, the suture threads that were used are unknown.Without this information, the root cause for the ripping of the suture threads cannot be determined.A non-conformity report had been opened in order to further investigate and address this issue for more details.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The following event was reported: surgery is indicated by the tearing of cerclage osteosynthesis sutures on two occasions with a horizontal stable-angle proximal humerus plate [from stryker].In depth preparation with delta-split entry.Location of the plate and swabbing of the humerus plate.If the knots are still intact, further preparation will involve cutting through the stitch cerclage.Mobilization of the fragment of the tuberculum majus and encirclement with a total of four fiber wire retraction sutures.The stitches are passed through the holes in the plates and knotted.Two sutures are already tearing.Removal of the plate and a renewed attempt in vitro with one suture.Here again the suture tears.The plate is obviously unsuitable and is therefore replaced with a proximal humerus plate from synthes.The total of four cerclages and knots are now passed through the suture holes.The final x-ray check shows a correctly positioned tuberculum fragment and also a correctly positioned synthes plate.This pi is for the 3rd medical intervention during which the plate was removed.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9244241
• Report Number: 0008031020-2019-01533
• Device Sequence Number: 16794208
• Product Code: HRS
• UDI-Device Identifier: 07613327091090
• UDI-Public: 07613327091090
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627204
• Device Lot Number: V10645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/28/2019
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60