MAUDE Adverse Event Report: ZIMMER GMBH CLS - AWL, EXTENDED; UNKNOWN

Catalog Number 70.08.89

Device Problems Material Separation (1562); Naturally Worn (2988); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.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 "welding is coming apart and is sharp" on (b)(6) 2016 on a cls - awl, extended.This was discovered by the sterilization team after surgery.The product is normal worn and torn.

Event Description

It was noticed by the sterilization team after the surgery that the welding was coming apart and was sharp.

Manufacturer Narrative

As per fda¿s directive, medwatch report has been resubmitted for removing three zeros in the prefix of mfr number(0009613350-2016-00133-1).All the information captured as per 0009613350-2016-00133-1 including g4(date received by manufacturer) except b4.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend identified.Review of event description: it is reported that during sterilization it has been noticed that the welding is coming apart and is sharp.Visual and/or functional examination: the weld at the connection between handle and beam is broken.It seems that the instrument broke apart and was reassembled.Several signs of hammering are visible on the handle.Possible route causes: possible causes for the reported event according to rm worksheet: line r-1.4.2: instrument, breaks, deforms, diverge, or parts remain in wound.- due to inadequate design for intended performance.Line r-1.4.8: instrument, breaks, deforms, diverge, or parts remain in wound.- due to mechanical properties of material insufficient.Line r-3.2.9: instrument breaks or deforms - due to off-label or abnormal-use.Comparison to investigation results whether it is possible and justification: not possible: as according to the complaint summary an adverse trend due to inadequate design would have been detected.Not possible: as the material compatibility specification certify the suitability of the material and the documents of material for the lot indicate that there was no material fault.It has to be considered that the instrument is more than 10 years on the market.Possible: as it is unknown how the instrument was used.It has to be considered that the instrument of this case is for 10 years on the market/in use.It is possible that the welding slightly got damaged during the long term use.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 gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: CLS - AWL, EXTENDED
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 5398594
• MDR Text Key: 37105198
• Report Number: 9613350-2016-00133
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 70.08.89
• Device Lot Number: 06.229088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other