MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AWL; N/A

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.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 supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

During the surgery, the t handle of the device (t handle awl) fractured.However, no pieces fell into the patient and no injury was sustained by the patient.There was no surgical delay.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Review of event description: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.Review of received data: - no medical data relevant to the case has been received.However, one image of low resolution of the fractured device has been received.It can merely be seen that the handle of the cls awl is detached from the schaft, possibly at the weld-site.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.The investigation did not identify a nonconformance or a complaint out of box (coob).No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part is unknown.However, one image of low resolution of the fracture device has been received.It can merely be seen that the handle of the cls awl is detached from the schaft, possibly at the weld-site.Based on the investigation the reported event can be confirmed.The reported product has been manufactured in the year 2004, which might have contributed to its fracture due to possible material fatigue at our around the weld-site.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).

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Additional information was received on aug 18, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received the device on aug 18, 2021.The investigation of the case is still ongoing.Should additional information become available or 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

Event happened during a left hip surgery.During the surgery, the handle of the device fractured.

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Investigation results were made available.Additional: d10, h2, h6.Correction: b4, b5, d9, g3, g6, h3, h10.1.Event description: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.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.However, one image of low resolution of the fractured device has been received.It can merely be seen that the handle of the cls awl is detached from the shaft, possibly at the weld-site.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: - the device was returned for examination.The handle fractured at the welding.The material at the fracture surface is brownish discolored and shows signs of corrosion.See images attached.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.5.Conclusion: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.The investigation did not identify a non-conformance or a complaint out of box (coob).Based on the visual examination the reported event can be confirmed.The reported product has been manufactured in the year 2004, hence recurrent usage (loading of the device), cleaning and sterilization may have caused or contributed to the reported event.Nevertheless, based on the given information and the results of the investigation, 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¿s reference number of this file is (b)(4).

Event Description

Product was received, investigation has been updated.

• Brand Name: AWL
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11320492
• MDR Text Key: 233045959
• Report Number: 0009613350-2021-00081
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 00889024301788
• UDI-Public: 00889024301788
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2021

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: 70.08.89
• Device Lot Number: 04127249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 08/18/2021; 09/15/2021
• Supplement Dates FDA Received: 06/22/2021; 09/03/2021; 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization