MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; SCREW, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032)

Event Date 02/19/2013

Event Type  Injury  

Event Description

It was reported a patient had a orif of the left distal humerus due to a traumatic fracture.Subsequently, shortly after the surgery, developed radial nerve palsy that involved wrist drop, loss of thumb extension and grip strength, making day to day activities difficult.The patient was placed in a splint and prescribed formal therapy.A nerve conduction test was completed and indicated severe radial neuropathy with signs of reinnervation.Over time, the patient continued to improve and was considered resolved with full functionality.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00351, 0001822565-2023-00352, 0001822565-2023-00374, and 0001822565-2023-00375.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00351, 0001822565-2023-00352, 0001825034-2023-00533, 0001822565-2023-00645, 0001822565-2023-00649, 0001822565-2023-00374, 0001822565-2023-00375.D10: distal medial humeral plate short left cat: 47235810807, lot: 61153872.Distal posterior/lateral humeral plate left 9 holes 150 mm length cat: 47235800609, lot: 61208368.3.5 mm locking screw with 2.7 mm head 12 mm length cat: 47235901238, lot: 61117349.2.7 mm locking screw 22 mm length cat: 47482802202, lot: 60646645.2.7 mm locking screw 12 mm length cat: 47482801202, lot: 60625467.Unk zplp 3.5mm locking screw qty: (b)(4).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h3, h6, h10.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00352, 0001825034-2023-00533, 0001822565-2023-00649, 0001822565-2023-00374, 0001822565-2023-00375, 0001822565-2023-01755, 0001822565-2023-01756, 0001822565-2023-01757, 0001822565-2023-01758, 0001822565-2023-01759.D10: distal medial humeral plate short left cat: 47235810807 lot: 61153872.Distal posterior/lateral humeral plate left 9 holes 150 mm length cat: 47235800609 lot: 61208368.3.5 mm locking screw with 2.7 mm head 12 mm length cat: 47235901238 lot: 61117349.2.7 mm locking screw 22 mm length cat: 47482802202 lot: 60646645.2.7 mm locking screw 12 mm length cat: 47482801202 lot: 60625467.2.7 mm locking screw 38 mm length cat: 47482803802 lot: 61126468.3.5 mm locking screw with 2.7 mm head 24 mm length cat: 47235902438.Lot: unknown unk screw qty : 5.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on 05 march 2013, orif has been performed with anatomic alignment.On 11-mar-2013 at a clinic visit noted pt developed radial nerve palsy, splinted and referred to hand therapist.On 09-apr-2013 at a clinic visit, noted pt doing well, x-ray- no significant findings, rom 30°-120° supination & pronation with very little pain, wrist drop with management of a wrist drop splint and therapy.Continue therapy and wean sling.On 02-jul-2013 at a clinic visit, noted pt developed a dense radial nerve palsy with complete loss of wrist and finger extension ¿ causing functional problems in day to day activities.Since she was last seen, she has had some recovery of wrist extension, mainly from the extensor carpi radialus longus.Now can extend wrist with gravity but unable to withstand resistance.(grade 3) no thumb or finger extension at the mcp joints.The thumb has advanced osteoarthritis of the metacarpal joint with severe adduction contracture which would not benefit from a function elp.Nerve conduction study results: ¿there is evidence of severe left radial neuropathy.This is axon loss lesion with signs of re-innervation of the main truck but only minimal reinnervation of the posterior interosseous branch.Further spontaneous improvement should be anticipated.¿ on (b)(6) 2014, noted feeling of tightness and stiffness in wrist and distal forearm but wouldn¿t describe as pain.Radial nerve function excellent today with strong wrist and finger extension.Conclude radial nerve palsy has recovered 90%.On (b)(6) 2014, clinic visit noted radial nerve palsy has resolved.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 Description

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

• Brand Name: UNKNOWN SCREW
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 16365763
• MDR Text Key: 309431881
• Report Number: 0001822565-2023-00353
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101073
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: N/A
• Device Lot Number: 60837245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HUMERAL PLATE CAT: 47235810807.; SEE H10.; UNKNOWN SCREW.; UNKNOWN SCREW.; UNKNOWN SCREW.
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 86 KG