MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH; PLATE, FIXATION

Catalog Number	00235908536
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The following could not be completed because the part/lot information could be: lot number - 62120799.Udi # (b)(4).Manufacture date ¿ jul 02, 2012.Or the part/lot information could be: lot number - 60705515.Udi # (b)(4).Manufacture date ¿ jun 11, 2007.Qty: 2 multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00838 (screw).0001822565 - 2022 - 00658 (plate).
Event or Problem Description
It was reported that patient was revised due to locking screws in proximal tibia plate backing out and not locked in properly.The issue had occurred due to the patient falling and the two longest screws had backed out as a result.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: (b)(4) (b)(4) the following sections were updated: b4; b5; d4; d6; d10; g1-2; g3; g6; h1; h2; h3; h4; h6 d10: medical products: item#: 00235700310, 3.5 mm proximal lateral tibial plate right 10 holes 152 mm length; lot#: 64298407 item#: 00235909036, 3.5 mm cannulated locking screw 90 mm length; lot#: 62098620 item#: 00235908536, 3.5 mm cannulated locking screw 85 mm length; lot#: 60705515 item#: 00235908536, 3.5 mm cannulated locking screw 85 mm length; lot#: 60705515 item#: 00235903835, 3.5 mm locking screw 38 mm length; lot#: 63748422 item#: 00235908036, 3.5 mm cannulated locking screw 80 mm length; lot#: 62121947 the conical thread form of the zplp 3.5mm cannulated locking screws exhibit damage which caused them to fail overlay 25-2001-560-06-l.The thread form of the shaft is conforming to overlay 25-2001-560-06-l except where damage is seen near the conical head.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: 3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13891338
• Report Number: 0001822565-2022-00840
• Device Sequence Number: 1764519
• Product Code: HRS
• UDI-Device Identifier: 00889024059504
• UDI-Public: (01)00889024059504(11)07022012(10)62120799
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K042598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00235908536
• Device Lot Number: 62120799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown