MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RATCHET HANDLE; INSTRUMENT

Catalog Number 2107-1000

Device Problem Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

It was reported during primary of total hip surgery the doctor noticed the plastic on handle of screwdriver was flaking.He continued the surgery with no delay.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

Reported event: an event regarding a damaged ratchet handle was reported.The event was confirmed.Method & results: device evaluation and results: medical records received and evaluation: the metal adaptor end showed signs of damage consistent with cyclic repeated use over a long term service life.The bottom of the black handle showed damage to the silicone over-mold.The device was shipped to the supplier for evaluation.The supplier's report stated: "the radius by the cannulated handle has been pounded flat removing the radius and closing up the cannulated hole." device history review: there were no reported discrepancies.Complaint history review: there have been no other events for the referenced lot.Conclusions: the ratchet handle is intended to torque screws into bone.The supplier evaluation report indicated the device showed damage consistent with repeated impaction.As the device is not intended to be impacted, but instead torqued, it is concluded that the root cause of the damage is user error.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

It was reported during primary of total hip surgery, the doctor noticed the plastic on handle of screwdriver was flaking.He continued the surgery with no delay.

• Brand Name: RATCHET HANDLE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4295531
• MDR Text Key: 5270165
• Report Number: 0002249697-2014-04515
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

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: 2107-1000
• Device Lot Number: BPYM03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2004
• 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
• Patient Age: 62 YR