MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS PR HUM TAR GD CNCT BLT; TRAUMA INSTRUMENT

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical product: humerus impaction head; catalog#: 110035647; lot#: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.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 the attachment for the insertion handle (the thread) jammed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: d1 investigation results are now available investigation and conclusion 1.Event description: it was reported that during surgery on (b)(6), 2021 whereby an affixus ph nail was being explanted, the attachment for the insertion handle (the thread) jammed in the thread and a cold weld occurred and could not be removed.However, the nail could be explanted and there was no impact to the patient.Harm: s1 - no patient, user, or other stakeholder harm hazardous situation: instrument breaks, diverges or becomes damaged and non-functional during surgical procedure.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.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.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 dhr review could not be performed due to missing product identification.Surgical technique: the surgical technique was reviewed and the nail assembly and insertion are covered starting on page 14/40, whereby the following is stated: assemble the connecting bolt through the guide barrel grip and mate to the desired nail implant.The utilization of the impaction head with the slotted mallet to drive the nail to the desired depth is explained on the following page.Additionally, extraction of the nail is covered on page 27/40, whereby the following is stated: attach the extraction adapter (ref.(b)(4)) to the proximal end of the nail implant.And then attach the slaphammer to the extraction bolt.Backslap on the nail until fully extracted.5.Conclusion: it was reported that during surgery on (b)(6) 2021 whereby an affixus ph nail was being explanted, the attachment for the insertion handle (the thread) jammed in the thread and a cold weld occurred and could not be removed.However, the nail could be explanted and there was no impact to the patient.Due to significant lack of information and missing lot number, a detailed investigation such as in the form of a review of the device manufacturing records could not be performed.Nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Due to the vaguely reported event, in particular the attachment for the insertion handle (the thread) jammed in the thread it is assumed that this is referring to the nail to connection bolt interface.Why the impaction head is listed on the product experience report (per) and its involvement is unknown.However, all the listed products in this complaint (connection bolt, targeting guide barrel grip, impaction head) are devices used during implantation of the affixus nail, as per surgical technique.According to the surgical technique, the recommended approach is to use the extraction adapter and attaching a slaphammer to the extraction bolt for extraction.If a deviation from the recommended surgical approach was performed however remains unknown as the clear nature and details of the event are unknown.Additionally, neither devices nor photos of the devices were received; therefore the condition of the components is unknown.Hence the reported event cannot be confirmed.Based on the given information and the results of the investigation, we were neither able to confirm the reported event nor identify a specific root cause for this issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

• Brand Name: AFFIXUS PR HUM TAR GD CNCT BLT
• Type of Device: TRAUMA INSTRUMENT
• 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: 12743987
• MDR Text Key: 281742985
• Report Number: 0009613350-2021-00554
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024506633
• UDI-Public: 00889024506633
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 110035672
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/03/2022
• 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