MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V1 LONG - LEFT; PLATE, FIXATION, BONE

Catalog Number	PLP10461
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling (2091)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It is alleged by the attorney through the filing of a legal claim, that the patient underwent surgery for a lapidus bunionectomy on (b)(6) 2017 where she was implanted with a left stryker mtp anchorage plate in her right foot.It is further alleged that on (b)(6) 2018, while walking in her cam boot, she felt and heard a crack in her foot and began to experience pain and swelling.X-rays revealed the plate stabilizing her first metatarsal had broken, which required revision surgery on (b)(6) 2018.They further allege the plate was broken through at the point of one of the screw holes.
Additional Manufacturer Narrative
The reported event that plate anchorage mtp / version v1 long - left was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by not selecting the appropriate implant.Anchorage devices are anatomically shaped and the surgeon implanted a left plate on a right foot.This choice is not optimal to help bone growth.In this obese patient, failure to gain compression and apposition of host bone rather than with dead allograft interposed resulted in the nonunion described.Cyclic loading at the nonunion site, which was beneath an empty screw hole, resulted in the inevitable fatigue fracture at this level as confirmed by the material analysis report.The anchorage plate system is an internal fixation system which shall fix bone segments in a correct position until sufficient bone consolidation is acchieved.The anchorage plating system is not intended to transmit full forces and bending moments of daily routine.Loading and weightbearing have to be individually reduced.Influence factors for the required load reduction are: the type and the localization of fixation, the bone quality (e.G.Strong bone in younger patients vs.Osteoporotic bone), correct fixation technique (e.G.Correct dimension of the plate, correct positioning of the plate, sufficient length of the plate and the screws.Sufficient bending of the plate, correct screw placement with sufficient insertion torque).Depending on these individual influencing factors the attending physician has to determine the maximum loading and has to limit the weight bearing respectively.This is part of the surgeon's education.Stryker offers labeling of best quality (op-tech, ifu) but stryker cannot grant that all users are skilled in the special field of podology and have read the labeling with diligence.In the case of an overloading or due to poor implantation technique implant failure may result.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It is alleged by the attorney through the filing of a legal claim, that the patient underwent surgery for a lapidus bunionectomy on (b)(6)2017 where she was implanted with a left stryker mtp anchorage plate in her right foot.It is further alleged that on (b)(6)2018 , while walking in her cam boot, she felt and heard a crack in her foot and began to experience pain and swelling.X-rays revealed the plate stabilizing her first metatarsal had broken, which required revision surgery on (b)(6)2018.They further allege the plate was broken through at the point of one of the screw holes.

• Brand Name: PLATE ANCHORAGE MTP / VERSION V1 LONG - LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7635367
• Report Number: 0008031020-2018-00481
• Device Sequence Number: 1861505
• Product Code: HRS
• UDI-Device Identifier: 07613252260424
• UDI-Public: 07613252260424
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PLP10461
• Device Lot Number: F39254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: 55 YR
• Patient Weight: 113