MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM

Model Number AB01

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that during a procedure conducted at the user facility a pin broke from a universal bone repositioning device.The sales representative stated that the remains of the instrument were left in the patient.No delay in surgery, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the product in question, nor is there any indication for a deviation from the defined quality specifications within development or manufacturing.No indications for unusual or unexpected circumstances could be identified, either.Moreover it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after expiration of their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.

Event Description

It was reported that during a procedure conducted at the user facility a pin broke from a universal bone repositioning device.The sales representative stated that the remains of the instrument were left in the patient.No delay in surgery, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6169196
• MDR Text Key: 62676377
• Report Number: 0008010177-2016-00292
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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 Model Number: AB01
• Device Catalogue Number: 62-32440
• Device Lot Number: M2100FC000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• 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