MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7 MM LOCKING SCREW 24 MM LENGTH; FIXATION, SCREW

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Irritation (1941); Nerve Damage (1979); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as they were discarded by hospital.Medical products 47235800505, distal posterior/lateral humeral plate right 5 holes 98 mm length, 62685139 47235810703, dist med hum lk plt shrt 3h rt, 61153867, 47482802002, 2.7 mm locking screw 20 mm length, 63062886, 47482803002, 2.7 mm locking screw 30 mm length, 62881175, 47482802202, 2.7 mm locking screw 22 mm length, 63075448, 47482803002, 2.7 mm locking screw 30 mm length, 62881175, 47482801802, 2.7 mm locking screw 18 mm length, 63470831, 47482802002, 2.7 mm locking screw 20 mm length, 62565038, 47482802202, 2.7 mm locking screw 22 mm length, 62634798, 47482801402, 2.7 mm locking screw 14 mm length, 63510330.Report source, foreign - the event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02571, 0001822565-2018-02572, 0001822565 - 2018 - 03250 , 0001822565 - 2018 - 03251 , 0001822565 - 2018 - 03252 , 0001822565 - 2018 - 03253 , 0001822565 - 2018 - 03254 , 0001822565 - 2018 - 03255 , 0001822565 - 2018 - 03256 , 0001822565 - 2018 - 03257.Not returned to manufacturer.

Event Description

It was reported that the patient was revised due to ulnar nerve symptoms.Two months prior to removal, patient presented with symptoms: warm, swollen, erythematous and crp <8.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp less than 8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of pictures of product provided and pathology report.As per the pathology report, adverse reaction to metallic debris/metallosis has been noted.But, there is no date of when the specimens were taken or pathology report.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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

It was reported that the patient was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp <8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: 2.7 MM LOCKING SCREW 24 MM LENGTH
• Type of Device: FIXATION, SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7602106
• MDR Text Key: 111141829
• Report Number: 0001822565-2018-03249
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK063303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2018

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
• Device Operator: Physician
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47482802402
• Device Lot Number: 62569488
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 07/20/2018; 11/16/2018
• Supplement Dates FDA Received: 08/17/2018; 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR