MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS LARGE FRAGMENT LG CANNULATED SCREWDRIVER HANDLE; ORTHOPEDIC SURGICAL MANUAL INSTRUMENT

Model Number N/A

Device Problems Bent (1059); Mechanical Problem (1384); Separation Failure (2547); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: lg cann screwdriver handle, cat#: 214149000 lot#: 697706, lg cann screwdriver handle, cat#: 214149000 lot#: 807134, humeral screwdriver, cat#: 281017017 lot#: 261354, 6.5mm screwdriver shaft, cat#: 281013024 lot#: a12bv4, 4.5/5.5mm screwdriver shaft, cat#: 281001015 lot#: sc1a006.The customer reported multiple malfunctions across multiple devices.However, it is unclear at this time what specific issue(s) this particular device is experiencing of the reported various problems.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03686, 0001825034-2018-03685.

Event Description

It was reported that the driver handles are difficult to remove from their attachments/drivers, are tilted, and that the handle spins, making it difficult to use during a procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information received.

Manufacturer Narrative

Visual inspection was performed on the returned devices and confirmed the driver bits that were stuck in the a/o connect portion of the handles.The supplier investigation found that the drivers were difficult to remove due to the shafts being forced into the drivers incorrectly and causing deformation of the retaining groove on the shafts.The driver bits have ball bearing damage from hammer usage.Hardness testing was performed on all three bits and the outer diameter and flat width were measured using micrometers; dimensions were conforming to print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Based on the information available, the root cause is determined as operational context caused or contributed to the reported event.A summary of the investigation was sent to the complainant.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.

• Brand Name: ALPS LARGE FRAGMENT LG CANNULATED SCREWDRIVER HANDLE
• Type of Device: ORTHOPEDIC SURGICAL MANUAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7551072
• MDR Text Key: 109501778
• Report Number: 0001825034-2018-03682
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 214149000
• Device Lot Number: 828421
• Other Device ID Number: (01) 00887868024610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1