MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the patient experienced a wound dehiscence and exposed plate in (b)(6) 2019 following implantation in (b)(6) 2019.In (b)(6) 2019, the exposed part of the resorbable plate was removed.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The l-plt rt reg 2.0 lactosorb sys (part# 915-2101, lot# unk) was not returned for investigation and no photos or physicians reports were provided.For these reasons, no visual evaluation or functional testing could be conducted.The dhr for this product could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (915-2101) and the previous one year (from the notification date) regarding the exposure of the plate through the patient's skin, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.It is possible that the plate was not properly shaped and contoured to the patient's anatomy, that the patient's activity resulted in wound dehiscence and loosening of the plate, or that the plate was near the skin surface and directly under the incision.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9428703
• Report Number: 0001032347-2019-00540
• Device Sequence Number: 2158581
• Product Code: HRS
• UDI-Device Identifier: 00841036054397
• UDI-Public: 00841036054397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention