MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BODY/STEM SEPARATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 6278-9-070

Device Problems Fracture (1260); Material Distortion (2977); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Items were hit with a mallet and bent/stuck together.

Manufacturer Narrative

An event regarding crack/fracture involving a restoration modular separator was reported.The event was confirmed.Device evaluation and results: the device was received and was found to have scratches throughout the surface indicative of heavy use.The jack screw, collect and puller are disassociated from each other.The adaptor end of the device was damaged.The tip of the instrument which connects to the implant showed damage near it's base.Examination of the returned device with material analysis engineer noted that the torsional overload fracture of the jackscrew subcomponent was observed.Medical records received and evaluation: not performed because the reported event is not related to clinical factors.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: a visual inspection of the returned device shows scratches throughout the surface indicative of heavy use.The jack screw, collect and puller are disassociated from each other.The adaptor end of the device was damaged.The tip of the instrument which connects to the implant showed damage near it's base.Examination of the returned device with material analysis engineer noted that the torsional overload fracture of the jackscrew subcomponent was observed.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Items were hit with a mallet and bent/stuck together.

• Brand Name: BODY/STEM SEPARATOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6775321
• MDR Text Key: 82088597
• Report Number: 0002249697-2017-02416
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6278-9-070
• Device Lot Number: TDEV701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other