MAUDE Adverse Event Report: ZIMMER GMBH NCB-PH TORQUE WRENCH 4 NM

Catalog Number 02.00024.022

Device Problems Fracture (1260); Mechanics Altered (2984); Positioning Problem (3009)

Patient Problems Bone Fracture(s) (1870); Complaint, Ill-Defined (2331)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the instrument for review.X-rays or other source documents were not provided for review.Where lot numbers were received for the instrument, the instrument history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that during the implantation surgery of a tm baseplate on (b)(6) 2015, a fracture of the patient's glenoid occured.It was reported by the surgeon that the reason was that the 4nm which are given by the ncb-ph torque wrench 4 nm are too high.It was further reported that the fracture of the glenoid was caused by the rotation forces and the bad bone quality.The surgery was completed with 60 min delay.

Manufacturer Narrative

Trend analysis: no trend identified.Compatibility of components: the compatibility check could not be performed as only one product was reported to us.The product compatibility check is not relevant for one product only.Review of incoming information: it was reported that when the surgeon was tightening into glenoid with the ncb torque wrench, a fracture of the glenoid occurred.The reason, according to surgeon, is that the torque in the wrench was to high and there was nothing to compensate the "excessive" torque.4 x-rays were returned.Review of the x-rays did not provide any information related to the issue of the tool complained in the event details.The implantation report stated that a (b)(6) lady had a polyfragmental fracture of the proximal right humerus, occurred after falling.The fracture was treated with an inverse shoulder prosthesis.During surgery, it was found out that the bone was of very poor quality.Moreover, it is stated that during tightening with the torque wrench, despite it was done very carefully (since it was well known that the bone was quite soft) it came to a crack noise and a glenoid fracture was noticed.No other conspicuous information available.Possible causes for the reported event: a.Unrecognized damaged instrument is used -> due to damaged instrument due to transport b.Damaged instruments, implants, body or wrong operational step -> due to surgeon or or staff unfamiliar with instrument usage and handling c.Damaged instruments, implants, body or wrong operational step -> due to surgeon or staff unfamiliar with instrument usage and handling d.Failure of surgery -> due to wrong selection of components or use in combination with device comparison to investigation results whether it is possible and justification; all possible due to the following reasons: a.Possible: it was possible that the device was damaged due to transport.B.Possible: it could be that surgeon or staff was unfamiliar with instrument usage.C.Possible: it could be that surgeon or staff was unfamiliar with instrument usage.D.Possible: it was possible that the surgeon used wrong selection of components.Device or photos were not received, therefore the condition of the component was unknown.Patient factors that may affect the performance of the components, such as bone quality, may have had a significant contribution to the unexpected fracture of the glenoid.However, as stated in the surgical report, surgeon was aware of the poor bone quality of the patient.In conclusion, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: NCB-PH TORQUE WRENCH 4 NM
• Type of Device: NCB-PH TORQUE WRENCH
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5049309
• MDR Text Key: 24822767
• Report Number: 9613350-2015-01042
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physical Therapist
• Type of Report: Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.00024.022
• Device Lot Number: 14.109160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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