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 Insufficient Information (4580)

Event Date 05/31/2019

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, p/n 450-0241, s/n (b)(4), 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 450-0241-11.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 unit was released on december 3rd, 2018 per the lot dhr.The suggested preventative maintenance (pm) is every six months.The complaint was filed on june 4th, 2019, six months and one day later.Therefore, this unit had been used in surgery for six months.Therefore, it was not beyond the pm time window.The bearings from the unit appear to be in good condition.The bearings are the maintenance item that shows wear during pm events.When the collet breaks off, it is actually the reciprocating shaft that breaks.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 030-1106, revision ae, and the osteopower stg, p/n 030-1179, revision p, both warn the user against the possibility of breaking the instrument due to forceful side loading.Upon examination, those units had damage to the plastic collet, which indicated they had been repeatedly hit by either other instruments or bone.The remaining units, including the device involved in this complaint, do not show any damage to the plastic collet.The root cause for the breakage was not determined.Review of the dhr did not identify any non-conformances associated with lot release.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 captured in risk documentation.

Event Description

On 04 june 2019, customer service was notified that "a piece of instrumental broke in surgery", and a photograph of the damaged saw was provided.Follow up attempts were made to obtain more information regarding the event and the patient to no avail.

• 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: 13242266
• MDR Text Key: 292732743
• Report Number: 2027754-2022-00001
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: (01)00845694037167(30)1(11)181121
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• 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: 06/04/2019
• 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