MAUDE Adverse Event Report: EXACTECH, INC. PRM STM INSRTR EXTRCT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 301-07-10

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that this instrument could have broken during surgery.However, the breakage has been noticed at the recovery of the instrumentation-set by our logistics dept., after the cleaning realized by the sterilization team of the hospital.No information has been received from the hospital regarding this issue and xnov ip didn't receive any request for complementary information regarding this issue as well.

Manufacturer Narrative

Section h10: (h3) the mostly likely underlying cause for the broken instrument reported cannot be determined as the device appears to function as intended.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: PRM STM INSRTR EXTRCT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15885310
• MDR Text Key: 307712131
• Report Number: 1038671-2022-01533
• Device Sequence Number: 1
• Product Code: JXH
• UDI-Device Identifier: 10885862079701
• UDI-Public: 10885862079701
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 301-07-10
• Device Catalogue Number: 301-07-10
• Device Lot Number: 72726013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK.