MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANKLE STRAP-PLASTIC; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Item requested but not yet received.

Event Description

It was reported that a new strap broke when it was tied to the extra medullary tibial cut guide.

Manufacturer Narrative

(b)(4).Complaint summary: as the product has not been received, the investigation was limited to the information provided and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 5 complaints reported with the item 32-421429 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product location unknown.

Event Description

It was reported that a new strap broke when it was tied to the extra medullary tibial cut guide.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information.Complaint summary: as the product has now been returned an investigation has now been carried out.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.Visual inspection of the returned part confirms a split in the silicon is present which appears to originate from the strap hole.The strap has experienced a split or tear across the full width or the strap, the product was most likely conforming to specification when distributed.With the limited information provided the root cause cannot be confirmed for the reported event.A review of the complaint database over the last 3 years has found 5 complaints reported with the item 32-421429 (including the initiating complaint).A visual inspection of this device shows this event does not differ from previous reported events for the oxford ankle strap, and as a result there is no change to the severity or occurrence for this event, and the reported event is still considered to be within the severity of the risk file.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a new strap broke when it was tied to the extra medullary tibial cut guide.

• Brand Name: OXF ANKLE STRAP-PLASTIC
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12106023
• MDR Text Key: 259719247
• Report Number: 3002806535-2021-00284
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 32-421429
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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