MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY TARGETING GUIDE STANDARD; INSTRUMENT SHOULDER

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): n/a.Concomitant medical product: catalog #: 00249000351, cephalomedullary lag screw retainer, lot # 64034744, catalog #: 00249003575, modular hex screwdriver, lot # 61584064, catalog #: 00249005001, modular handle ao, lot # 64487989, catalog #: 00249007543, freehand drill, lot # unknown, catalog #: 00249003244, cephalomedullary lag screw reamer, lot # 64035390.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the zimmer cm nail carbon fiber targeting arm/insertion guide became misaligned; causing slight impingement on: the lag screw reamer, lag screw insertion device, 4.3 distal screw drill, and distal screw.It was not certain if the surgeon mistakenly hit the targeting arm causing the misalignment.The implants were very difficult to insert.The difficult insertion caused excess wear and tear on the lag screw retaining shaft as well as the short 3.5 hex driver and blue ao screw driver.The case proceeded without any knowable indecent to the patient.Intra-op fluoroscopic imaging was used to confirm the implants did not suffer any damage after insertion.Attempts have been made and there is no additional information available at this time.

Manufacturer Narrative

(b)(4).D11 - medical product: catalog #: unknown, connecting bolt, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.The visual examination of the guide showed some wear, however the connecting bolt was not returned to confirm the reported event.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CEPHALOMEDULLARY TARGETING GUIDE STANDARD
• Type of Device: INSTRUMENT SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10407036
• MDR Text Key: 202982336
• Report Number: 0001822565-2020-02909
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: 00249000300
• Device Lot Number: 63766141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1