MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI S.B.1998-191216 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; 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 there was an unspecified fit issue with a custom cranial implant.The implant was modified intraoperatively and successfully implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that a custom cranial implant was too large in an area and temporally it was too thick.The implant was modified intraoperatively and successfully implanted.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.No product was returned, as it was reported the implant was modified to complete the procedure.No x-rays, scans, pictures, or physician's reports were provided.The design vendor and manufacturer of this device was notified of the fit issue and performed an investigation and provided their results.The design vendor found that the implant met all product requirements of a standard fit + 0.75mm implant, as requested on the design input form.The design vendor found that the thickness in certain portions of the temporalis region was greater than 6mm.It was stated that the thickness of this region could have been reduced more to accommodate preferences, but the implant was manufactured appropriately per the instructions.The dhr was reviewed, no non-conformances were found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) in the previous year (from the notification date) regarding fit issues with the implant, the calculated complaint rate is 1.07% which is no greater than the occurrence listed in the application fmea.The root cause of this complaint was determined to be outside the scope of the design/manufacturing process.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: HTR-PMI S.B.1998-191216 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9920605
• Report Number: 0001032347-2020-00199
• Device Sequence Number: 11366716
• Product Code: KKY
• UDI-Device Identifier: 00841036279875
• UDI-Public: 00841036279875
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K924935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2020

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 Expiration Date: 01/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PM622821
• Device Lot Number: 963150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/17/2020; 09/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/07/2020; 09/16/2020
• 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