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

Catalog Number	PLP10461
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device is not available.
Event or Problem Description
The hospital pharmacy reported to the sales rep an event regarding an arthrodesis plate ref: plp10461.In which they indicate presence of metal fragments observed after drilling and inserting of the screws into the plate.Feedback received from the surgeon on march 6th indicate that he does not confirm the adverse event.He indicated that he gave too much angulation to his screw, which during the screwing process deposited a titanium thread which was removed.He was not even informed of the declaration of material vigilance by the pharmacy.The surgeon has completed his operation and is very satisfied with it.No clinical consequences, no delay in intervention and no additional intervention.
Additional Manufacturer Narrative
The reported event could not be confirmed, as the device was not returned and that the information received from the customer confirmed that the event is indeed a user related issue and not product related.The metal debris was due to a wrong angulation of the screw while tightening it into the plate as reported by the customer.The debris were removed, and the surgeon was satisfied with the result.The operative technique states: "perform drilling through locking or nonlocking drill guides according to the screw diameter to be utilized.Distal holes can accommodate either locking or nonlocking screws in 3.0mm (blue) or 3.5mm (yellow) diameter.Screws should be placed from medial to lateral.A 2.0mm drill bit (b)(4) (for 3.0mm screws) or 2.5mm drill bit (b)(4) (for 3.5mm screws) can be used in conjunction with the appropriate drill guide to prepare the hole for screw insertion.Insert screw after determining screw length with the gauge (b)(4).Note: a nonlocking screw can be inserted prior to introduction of locking screws to flush the plate to the bone surface." therefore, this case is classified as a user related issue.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.
Event or Problem Description
The hospital pharmacy reported to the sales rep an event regarding an arthrodesis plate ref: (b)(4).In which they indicate presence of metal fragments observed after drilling and inserting of the screws into the plate.Feedback received from the surgeon on march 6th indicate that he does not confirm the adverse event.He indicated that he gave too much angulation to his screw, which during the screwing process deposited a titanium thread which was removed.He was not even informed of the declaration of material vigilance by the pharmacy.The surgeon has completed his operation and is very satisfied with it.No clinical consequences, no delay in intervention and no additional intervention.

• 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: 8453743
• Report Number: 0008031020-2019-00317
• Device Sequence Number: 1436309
• Product Code: HRS
• UDI-Device Identifier: 07613252260424
• UDI-Public: 07613252260424
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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 Catalogue Number: PLP10461
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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: Other