MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) BEIN DENTAL ELEVATOR, 2MM, STRAIGHT; INSTRUMENT

Catalog Number 09-23200

Device Problems Bent (1059); Break (1069)

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

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported by the customer representative that he had a customer stating via email that they purchased 7 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago; the product number on them is ce 09-23201, and all of their tips have either bent, chipped or broken during use.Upon investigation it was noted that 6 elevators were purchased over a year ago.In (b)(6) 2015, (b)(4) was issued for 2 units.

Manufacturer Narrative

The reported event that the tip of the devices have bent could be confirmed.The visual examination revealed that the tips of the devices are bent compared to their original shape and show deformations due to mechanical overload.Both the dhr review and the hardness measurements performed showed that the devices were manufactured according to specification.Most likely too high bending forces were applied to the tip during usage, leading to a deformation.Therefore the root cause can be tied to a user related issue.Indications for any material, manufacturing or design related problems were not determined in the investigation.

Event Description

It was reported by the customer representative that he had a customer stating via email that they purchased 7 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago; the product number on them is ce 09-23201, and all of their tips have either bent, chipped or broken during use.Upon investigation it was noted that 6 elevators were purchased over a year ago.In (b)(6) 2015, pr# (b)(6) was issued for 2 units.

• Brand Name: BEIN DENTAL ELEVATOR, 2MM, STRAIGHT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg 79111 ; GM 79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg 79111 ; GM 79111
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg 79111 ; GM 79111 ; 76145120
• MDR Report Key: 5021837
• MDR Text Key: 24679670
• Report Number: 0008010177-2015-00208
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/15/2015

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: 09-23200
• Device Lot Number: AD03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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