MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS SMALL FRAGMENT HOOK DEPTH GAUGE 70MM; GAUGE, DEPTH

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Foreign-(b)(6).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It is reported that during a trauma plating procedure, the surgeon noticed that there was a significant length difference between the screw and the hook depth gauge as the gauge was measuring too large.The surgery was successfully completed with another hook depth gauge, however, a hour delay did occur due to the malfunction.No further patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Dimensional analysis identified that the gauge is measuring incorrectly.The scale was measured and found to be conforming.Further investigation of the subcomponents identified that the scale of the depth gauge had been swapped and was assembled with an incorrect, incompatible body, thus leading to the discrepancy.The scale component was assembled with its appropriate mating body, and the part functioned as designed and was conforming to specification.Device history record (dhr) was reviewed and no discrepancies were found.Root cause is related to the hospital swapping the scales from the two similar devices, likely during sterilization.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALPS SMALL FRAGMENT HOOK DEPTH GAUGE 70MM
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7582199
• MDR Text Key: 110480346
• Report Number: 0001825034-2018-03830
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 824100070
• Device Lot Number: SC15G002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization