MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW REAMER, SHORT; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received the device and investigation is in progress.X-rays or other source documents were not provided for review.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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.(b)(4).

Event Description

A znn cmn lag screw reamer short was used in a surgery on (b)(6) 2017.It was reported that during drilling process, the 3.2 guide wire in the drill got jammed.The tip of the drill was damaged.The surgery was completed with the second instrument of the hospital with 10 minutes delay.

Manufacturer Narrative

No trend considering the following event is identified: tip of reamer broken.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that during implantation of a znn cmn lag screw, the 3.2 guide wire got jammed inside the reamer and subsequently the tip of the reamer broke.No medical data such as surgical notes or any other case-relevant documents received.Devices analysis - visual examination: the reamer was returned for an investigation.There is a crack in one cutting blade of the reamer.There are some discolorations along the crack, which have probably occurred during sterilization of the damaged instrument at zimmer biomet.No other conspicuousness found.- hardness test: the hardness of the material was tested.With a measured value of 54-56 hrc it was found to be within the specifications of 55±3 hrc defined in aau q.20.256 (hardening and tempering of 1.4112/1.2361) for material 1.4112.Review of product documentation - inspection plan - characteristic no.19 feature "aauq 26.256 vergueten / harden and temper /1.4112¿ with scope of testing: 100%.Means of inspection: "visual".- characteristic no.22 feature "werkstoff / material: 1.4112/ aauq 26.505¿ with scope of testing: 100%.Means of inspection: "visual".- characteristic no.39 feature "dimension ø3.5 0.05/-0.05¿ with scope of testing: aql 1.0.Means of inspection: "prüfstift / test pin".Root cause analysis root cause determination using rmw: - instrument, breaks, deforms, diverge, or parts remain in wound.Due to inadequate design for intended performance not possible -> a systematic issue with design would have been detected as part of the issue evaluation assessment.- instrument, breaks, deforms, diverge, or parts remain in wound.Due to mechanical properties of material insufficient not possible -> a systematic issue with material properties would have been detected as part of the issue evaluation assessment.- fracture of instrument due to general corrosion (crevice, pitting, galvanic) not possible -> as visual examination showed no signs of corrosion.- instrument, breaks, deforms, diverge, or parts remain in wound.Due to inadequate design for intended performance not possible -> a systematic issue with design would have been detected as part of the issue evaluation assessment.- damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling => possible, as it cannot be excluded based on the available information.- damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling => possible, as it cannot be excluded based on the available information.- instrument breaks or deforms due to off-label / abnormal-use => possible, as it cannot be excluded based on the available information.Conclusion summary the reamer was returned for an investigation and it can be confirmed that there is a crack in one of the cutting blades.The hardness test confirmed, that the material hardness is within the specifications.One possible root cause might be, that the 3.2 mm pin was slightly bent or has migrated.Consequently, the reamer could have come into contact with the pin, leading to the breakage of the cutting blade.Therefore it is described in the surgical technique of the zimmer natural nail that during drilling, the c-arm should be used intermittently to verify the position of the reamer.Moreover, the bone quality of the patient could have also influenced the event.However, 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: ZNN CMN LAG SCREW REAMER, SHORT
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6607474
• MDR Text Key: 76513083
• Report Number: 0009613350-2017-00762
• Device Sequence Number: 1
• Product Code: HSB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-2490-003-64
• Device Lot Number: 16.277660
• Other Device ID Number: 00889024276260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1