MAUDE Adverse Event Report: ZIMMER GMBH TC - PLT CUT CLAMP 11.5CMSYS 1.0/1.2/1.7

Model Number N/A

Device Problem Break (1069)

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

Event Date 04/27/2012

Event Type  No Answer Provided  

Manufacturer Narrative

The manufacturer did not receive the instrument for investigation.No surgical report or x-rays were provided for review.As an incorrect lot number was provided for the instrument, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the surgeon was using a plate cutter clamp tc - plt cut clamp 11.5cmsys 1.0/1.2/1.7 during surgery on (b)(6) 2012.It was reported that the pliers broke the tip during cut of the mesh.No other information was provided.Note: three instruments with the same catalogue number and different (incorrect) lots were mentioned in the source document.Since no single instrument can be related to this patient/event, three reports where filed for the same patient/event, one for each instrument (see mfr 9613350-2016-00467 and mfr 9613350-2016-00468).

Manufacturer Narrative

Trend analysis: a trend was identified.A trend investigation has been initiated.Device history records (dhr): the dhr check could not be performed as the lot number was not available.Event summary: it was reported that the tip of the device broke when cutting the mesh.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Root cause analysis: neither x-rays, operative notes, office visit notes, nor devices or photos of the instrument were received; therefore the condition of the component is unknown.Reported event does not reveal any conspicuous information.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.However, all possible causes related to the issues reported are listed.Conclusion summary: neither products nor photos of the products are available for investigation.Poor information about the event received.Therefore, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: TC - PLT CUT CLAMP 11.5CMSYS 1.0/1.2/1.7
• Type of Device: TC - PLT CUT CLAMP 11.5CMSYS 1.0/1.2/1.7
• 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: 5497806
• MDR Text Key: 40240563
• Report Number: 9613350-2016-00469
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 503004198
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR