MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH STHMER/WEBER MEDULLARY PLUG WITH DRAIN, PE, CEMENTED, 3/14 MM; POLYETHYLENE MEDULLARY PLUG - STIIHMER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

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 the device 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

During a surgery while implanting the drain it fractured and the fractured pieces were left in the patient.Any kind of surgical delay is unknown.

Manufacturer Narrative

Event description: it was reported that during a surgery on mar 29, 2021 it was reported that while implanting the drain it fractured.The fractured piece is left in patient.It is unknown whether if the event occurred during an initial or revision surgery.Any kind of surgical delay is unknown.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.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown lot number.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Biocompatibility: femoral medullary plugs meet the iso 10993-1 biocompatibility.Requirements for orthopedic implants; and the drain and the connection cup meet the iso 10993-1 biocompatibility requirements for orthopedic instruments.Conclusion: it was reported that during a surgery on mar 29, 2021 it was reported that while implanting the drain it fractured.The fractured piece is left in patient.It is unknown whether if the event occurred during an initial or revision surgery.Any kind of surgical delay is unknown.Neither the device nor photos of the device were received; therefore the condition of the component(s) is unknown.Further, the lot number is unknown, therefore a review of the manufacturing records was not possible.Based on the investigation the reported event cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, the biocompatibility showed that the drain is released as an instrument and not intended for implantation.Therefore, we advise to monitor the patient closely.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).

Event Description

No change to previously reported event.

• Brand Name: STHMER/WEBER MEDULLARY PLUG WITH DRAIN, PE, CEMENTED, 3/14 MM
• Type of Device: POLYETHYLENE MEDULLARY PLUG - STIIHMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11805858
• MDR Text Key: 252707455
• Report Number: 0009613350-2021-00207
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• PMA/PMN Number: K830949
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 3223
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization