MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 14MM RAPID FLAP; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical products: baxter fibrin sealant patch, part# ni, lot# ni; johnson and johnson evical fibrin sealant, part# ni, lot# ni; unknown pds sutures, part# ni, lot# ni.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 bio-absorbable cranial fixation clamps fractured intra-operatively during a infratentorial craniotomy.Another pack of bone clamps was opened but were found in an unusable condition.The fascia sutures, fibrin patch and fibrin sealant that were already in place were removed to facilitate removal of the fractured cranial fixation clamps, resulting in a 20 minute delay.The patient was closed with pds sutures.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 non-verifiable.The lacto 14mm rapidflap clamp (item# 915-0020, lot# 615760, qty 3) were not returned for investigation and no photos were provided.For these reasons, no visual inspections or functional testing could be conducted.The dhr for these products was reviewed, no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 915-0020, lot# 615760.The most likely underlying cause of the complaint cannot be determined.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: LACTOSORB SYSTEM 14MM RAPID FLAP
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9872164
• Report Number: 0001032347-2020-00185
• Device Sequence Number: 3041584
• Product Code: JEY
• UDI-Device Identifier: 00841036053864
• UDI-Public: 00841036053864
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K003281
• 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
• Report Date (Section B): 07/31/2020

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 Expiration Date: 05/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: 615760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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: 3 YR
• Patient Weight: 17