MAUDE Adverse Event Report: OSTEOMED, LLC QUICK CONNECT RECIPROCATING SAW; HANDPIECE, ROTARY BONE CUTTING

Model Number 450-0241

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed late because of an oversight during the investigation of this complaint in 2019 and subsequent recent review of complaints due to new management and postmarket personnel determined this complaint is mdr reportable.The following is the investigation performed at the time of this complaint in 2019: a single quick connect reciprocating saw was returned to osteomed for evaluation.The reciprocating shaft was broken just at the start of the threads.The remainder of the threaded section was stuck in the lock collet, p/n (b)(4).The head, or collet, of the device broke off due to a large stress (side load) being applied to the collet during use.That load exceeded the material capability of the reciprocating saw shaft and it broke.The break is in the first few threads in the neck where the material decreases in diameter and is no longer supported by other structures in the handle.This device is used with saws to cut bones and teeth.The suggested preventative maintenance (pm) is every six months.This device had its last preventative maintenance (pm) in april of 2017, well outside of the pm schedule.The bearings from these units are what "wear out" and can lead to premature failure without indicated replacement and/or lubrication.There have been six incidents where the collet (head) of the instrument broke off in the past two years.When the collet breaks off, it is actually the reciprocating shaft that breaks.In each of the six occurrences, the shaft has broken in the same location.Some of the complaints have been attributed to improper surgical technique.That being that the surgeon applied excessive side load to the collet assembly during use, which directly led to the breakage.The osteopower ifu, p/n (b)(4), revision ae, and the osteopower stg, p/n (b)(4), revision p, both warn the user against the possibility of breaking the instrument due to forceful side loading.Upon examination, this device had damage to the plastic collet, which indicated it had been repeatedly hit by either other instruments or bone.The returned unit had not been properly maintained, and the damage to the collet is an indicator that the unit had been forcefully hitting either other instruments or bone during use.The root cause for the breakage was not determined.A two-year review did not identify any capas related to this instrument.A two-year review of the ncr database found six unrelated events.The osteopower risk management documentation was reviewed and the risk is caputured in risk documentation.Due to 6 occurrences of this issue within the last two years, the engineering manager and power product manager were alerted of this trend.This issue will be monitored through routine trending.

Event Description

On 20 july 2019, the surgeon was using the receiprocating saw to cut the mandible with a 451-2015-sp blade.As he was cutting the mandible, the saw head broke off.No injury or adverse harm was caused to the patient.

• Brand Name: QUICK CONNECT RECIPROCATING SAW
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: elhum wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 13242267
• MDR Text Key: 294039562
• Report Number: 2027754-2022-00002
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450-0241
• Device Catalogue Number: 450-0241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White