MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number UNK_INS

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Device not available for return.

Event Description

It was reported during an open reduction internal fixation for a left acetabular fracture, two stryker drill bits used with a cd4 handpiece allegedly fractured and remained inside the patient after the procedure.It was also reported the plaintiff sustained serious and permanent injury, pain and suffering.No further information was provided.This report is for the cd4 handpiece in use at the time of the alleged drill bit fractures.

Manufacturer Narrative

Based on further review of the reported event, there is no indication the handpiece malfunctioned in a manner that caused or contributed to this event.This handpiece is deemed concomitant to the associated cutting accessories.The malfunction of the cutting accessories was reported separately on mfr report numbers 0001811755-2019-00033 and 0001811755-2019-00032.This report does not represent a reportable malfunction.

Event Description

It was reported during an open reduction internal fixation for a left acetabular fracture, two stryker drill bits used with a cd4 handpiece allegedly fractured and remained inside the patient after the procedure.It was also reported the plaintiff sustained serious and permanent injury, pain and suffering.No further information was provided.This report is for the cd4 handpiece in use at the time of the alleged drill bit fractures.

Manufacturer Narrative

Due to the legal nature of this complaint neither the device or medical records are available for review.Device not returned.

Event Description

It was reported during an open reduction internal fixation for a left acetabular fracture, two stryker drill bits used with a cd4 handpiece allegedly fractured and remained inside the patient after the procedure.It was also reported the plaintiff sustained serious and permanent injury, pain and suffering.No further information was provided.This report is for the cd4 handpiece in use at the time of the alleged drill bit fractures.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8226163
• MDR Text Key: 132354478
• Report Number: 0001811755-2019-00043
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/11/2018; 06/07/2019
• Supplement Dates FDA Received: 05/15/2019; 06/20/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other