MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, RIGHT,10 MM, 18 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

Model Number N/A

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that, operation was performed with nail.Although the customer tried to connect the nail to guide with bolt, the bolt didn't turn and stuck.Then the customer used a backup nail and it was able to connect with out any problems.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported that during surgery on (b)(6), 2021, the surgeon tried to connect the cmn femoral nail to the targeting guide with the connecting bolt.However, the connecting bolt could not be connected after multiple attempts and got stuck.The surgeon then used a backup nail with a slightly different ccd angle to complete the surgery.A surgical delay of up to 15 minutes was reported.Harm: s2 - exposure to anesthesia, minor hazardous situation: instrument cannot be used with, or detached from, a mating instrument or mating implant as intended.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Images: nine images of the involved devices (cmn femoral nail and connecting bolt) were received of which five of these images show the nail and four show the bolt.Four images of the nail show the area of interest, namely the thread of the nail.Some polishes surfaces on and around the thread as well as signs of abrasion around the circumference of the 13.5h7 bore hole can be seen.One image of the bolt shows two bolts next to each other.It remains unknown which bolt is the complained product and which one was used to complete the surgery.The lot numbers of both of the bolts are the same (13765813).No apparent conspicuousness on either the thread of the bolts or the bolts in general can be seen, apart from several signs of usage (scratches).On another image the product id of both bolts can be seen (00-2490-003-04).On two further images the lot numbers of each bolt is shown (13765813).3.Product evaluation: visual examination: only the reported cmn femoral nail was received for investigation.The m11 thread shows polished surfaces.Signs of abrasion can be seen on the circumference of the 13.5h7 bore hole, in particular below both grooves of the bore hole.There is a thin abrasive line running along the circumference of the bore hole.These mentioned phenomena likely can be attributed to the reported event, whereby it was attempted multiple times to connect the bolt to the nail.Functional test: a functional test was performed with two different m11-6h thread limiting plug gauges (pm071101506h, z8833 and 063.313.801-v50-11), which passed.The good side of the gauges can be threaded with the nail.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Correspondence with shop floor (dl1789524): a potential correlation of the reported event to a known issue of coaxiality (ie-17143) for the nails can be ruled out, 5.Conclusion: it was reported that during surgery on (b)(6), 2021, the surgeon tried to connect the cmn femoral nail to the targeting guide with the connecting bolt.However, the connecting bolt could not be connected after multiple attempts and got stuck.The surgeon then used a backup nail with a slightly different ccd angle to complete the surgery.A surgical delay of up to 15 minutes was reported.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).No medical records related to the reported event were received.Images of the nail as well as two involved connection bolts of the same lot number were received.It remains unknown which bolt is the complained product and which one was used to complete the surgery.No apparent conspicuousness on either the thread of the bolts or the bolts in general can be seen, apart from normal signs of usage.However, the evaluation of the condition of the connection bolts is limited to the views and quality of the images that were provided.None of the connection bolts were returned for investigation.Only the cmn femoral nail was returned.The thread shows polished surfaces.Signs of abrasion can be seen on the circumference of the 13.5h7 bore hole, in particular below both grooves of the bore hole.There is a thin abrasive line running along the circumference of the bore hole.These mentioned phenomena likely can be attributed to the reported event, whereby it was attempted multiple times to connect the bolt to the nail.A functional test was performed with two different thread limiting plug gauges, with both tests passing.Therefore, the reported event cannot be confirmed.Due to neither of the connection bolts being returned for investigation, a thorough investigation of these devices as well as their interaction with the received cmn femoral nail can not be performed.Additionally, both connection bolts were manufactured in 2013.It can be therefore assumed that these devices were used for multiple procedures and possibly show signs of wear or even deformation on the thread, although not clearly seen on the images provided, potentially affecting its functionality and thus contributing to the reported event.However, 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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00673.

• Brand Name: CMN FEMORAL NAIL, CCD 125, RIGHT,10 MM, 18 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12796088
• MDR Text Key: 281594913
• Report Number: 0009613350-2021-00564
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120715
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 47-2493-180-10
• Device Lot Number: 3025833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1