MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED PECTUS STABILIZER; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00156.Medical products: pectus system 15 pectus support bar, part# 01-3715, lot# unk.Pectus system elongated pectus stabilizer, part# 01-3801, lot# unk.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
Event or Problem Description
It was reported a pectus bar and stabilizer was removed in a revision approximately eight months post-operatively after the bar slipped out of the stabilizer.The devices were removed and were not replaced.Twelve to eighteen months following the revision, a ravitch procedure is planned.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The two (2) elongated pectus stabilizer (part# 01-3801, lot# unk) were not returned for investigation; therefore, no inspections or functional testing could be conducted.Scans were provided, which show that the pectus support bar had disengaged from one of the two stabilizers and that stabilizer also appeared to be loose on one side.The dhr for this device could not be reviewed due to the lot numbers remaining unknown.There are no indications of manufacturing defects.For this part (01-3801) and the previous one year (from the notification date) regarding the migration of the implant, 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 patient's excessive movement caused the suture to come out of the stabilizer allowing the pectus bar to move.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.

• Brand Name: PECTUS SYSTEM ELONGATED PECTUS STABILIZER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9813288
• Report Number: 0001032347-2020-00157
• Device Sequence Number: 3002248
• Product Code: HRS
• UDI-Device Identifier: 00841036011093
• UDI-Public: 00841036011093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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
• Patient Age: 18 YR