MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW; BONE SCREW; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation 1.5 x 4 mm lactosorb screw catalog #: 915-2315 lot #: 828000, biomet microfixation 2.0 x 5 mm lactosorb screw catalog #: 915-2300 lot #: 801350, unknown 5 mm drill catalog #: ni lot #: ni, unknown 6 mm tap catalog #: ni lot #: ni.Therapy date: (b)(6) 2017.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, they were discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00131 and 0001032347-2018-00133.

Event Description

It was reported the fixed first and second screws fractured or came out of the patient's temporal bone when the surgeon attempted to insert the third screw to fix the square plate.After that, the surgeon drilled and tapped using the 5 mm drill and the 6 mm tap, when he attempted to insert the screw fixation could not be achieved the screw idly rotated.The surgery was complete using surgical sutures to fix the autogenous bone and bone flap without any delay.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Product identities could not be confirmed due to the products not being returned.Visual inspection and functional testing could not be performed due to the products being scrapped and not being available for return.In addition, there were no photographs, x-rays, scans or physician reports to substantiate the complaint.Therefore, the complaint cannot be verified and the most likely underlying cause cannot be determined.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) also has the following information in the section titled precautions: instruments are available to aid in the accurate implantation of lactosorb¿ fixation devices.Intraoperative fracture of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments that have experienced extensive use or excessive force are susceptible to fracture.Surgical instruments are only to be used for their intended purpose.All instruments are to be regularly inspected for wear and disfigurement.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00131-1 and 0001032347-2018-00133-1.

• Brand Name: 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW
• Type of Device: BONE SCREW; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7352242
• MDR Text Key: 102858449
• Report Number: 0001032347-2018-00132
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• PMA/PMN Number: PK012409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 915-2315
• Device Lot Number: 756970
• Other Device ID Number: (01)00841036055189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR