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

Model Number	PLP10342
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "our distributor informed stryker (b)(4) that after a surgery performed on (b)(6) 2019, on (b)(6) 2019 a radiographical check revealed the device broken.Revision surgery performed on (b)(6) 2020 with 2 aurofix screws.".
Additional Manufacturer Narrative
Method code.
Event or Problem Description
As reported: "our distributor informed stryker italia that after a surgery performed on 06/21/2019, on 9/10/2019 a radiographical check revealed the device broken.Revision surgery performed on (b)(6) 2020 with 2 aurofix screws.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed that the plate is indeed broken.The breakage surface showed a shiny surface, a clear sign of a fatigue fracture.The plate broke at one point and the two sides of the broken plates were rubbing against each other (thus the shiny breakage surface).Moreover, the x-rays were shared and reviewed by stryker's medical expert, the medical opinion on this case is the following: " the complaint is clear, the plate broke.The plate was implanted in(b)(6)2019.During routine control and x-ray was taken, which showed the broken plate.It is unclear whether there were symptoms.The broken plate was diagnosed in (b)(6)2019.After reviewing the available documents a clear root cause cannot be given.The x-rays might show the clinical signs of a hypertrophic non-union.This non-union can be the cause of the plate breakage, due to continuous motion in the bones which need to fuse.Or it is the other way around, the plate broke which caused continues motion in the wrist bones, which led to the non-union due to the loss of stability." therefore, based on the current information, the exact root-cause of the event could not be established.A review of the device history was not possible because the lot number was not communicated.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "our distributor informed stryker italia that after a surgery performed on(b)(6)2019 , on(b)(6)2019 a radiographical check revealed the device broken.Revision surgery performed on (b)(6)2020 with (b)(4) aurofix screws.".

• Brand Name: PLATE ANCHORAGE MTP / VERSION V1 - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10161893
• Report Number: 0008031020-2020-01701
• Device Sequence Number: 3573241
• Product Code: HRS
• UDI-Device Identifier: 07613252260455
• UDI-Public: 07613252260455
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020

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 Model Number: PLP10342
• Device Catalogue Number: PLP10342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 08/13/2020; 10/08/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/02/2020; 11/04/2020
• 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