MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number UNK_ICO

Device Problem Fracture (1260)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was initially reported via the customer that the blade was stuck in the handpiece saw.It was subsequently reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece saw.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was initially reported via the customer that the blade was stuck in the handpiece saw.It was subsequently reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece saw.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10425202
• MDR Text Key: 203480739
• Report Number: 0001811755-2020-02197
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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 Catalogue Number: UNK_ICO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8206000000 (B)(6); 8206000000 (B)(4)