MAUDE Adverse Event Report: OSTEOMED OSTEOPOWER; RECIPROCATING SAW, QUICK RELEASE

Catalog Number	450-0241
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abrasion (1689); Burn(s) (1757); Burn, Thermal (2530)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A quick connect reciprocating saw, p/n 450-0241, and photos of the abrasion to the patient were supplied to osteomed.The description of the event as relayed in the complaint indicated that the surgeon was at fault, "user error", in allowing the collet of the saw become damaged by hitting another instrument.Afterwards, the surgeon allowed the running reciprocating saws' collet to touch the lower lip of the patient causing the abrasion.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 only found one, ncr 2018-0022 which was unrelated, it dealt with a finish on the housing that did not match earlier housings.This is the only complaint for this issue, "skin abrasion by contact with reciprocating collet", discovered in a two-year review of the complaint database.The quick connect reciprocating saw, p/n 450-0241, is a part of the osteopower 2 and 2i system.The osteopower risk document covers the risk of patient harm due to user error where the surgeon allows the moving collet to touch the patients' skin during the procedure is not currently in the fmea.This would have a high severity rating.A change notification has been created to add this risk to the fmea.The osteopower instructions for use (ifu) is p/n 030-1106, revision ae.In the cutting accessories section it states, "the surgeon should be thoroughly familiar with the proper operations of the powered surgical instruments and accessories prior to use." this issue will be monitored through routine trending.
Event or Problem Description
On (b)(6) 2019, the distributor contacted osteomed concerning an adverse event.Per the complaint, the reciprocating saw burned/caused abrasion on patient's lip/face.The quick detach black collar rubbed (possibly an instrument) and started to disintegrate leaving rough edges which then caused the injury during orthognathic surgery.

• Brand Name: OSTEOPOWER
• Common Device Name: RECIPROCATING SAW, QUICK RELEASE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 9119485
• Report Number: 2027754-2019-00014
• Device Sequence Number: 560438
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 450-0241
• Device Lot Number: 1014710
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Weight: 89