MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, 4X22MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	01/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: proximal humerus, right, long, 8.5x260mm; catalog#: 47249626008; lot#: 3026739.Cortical bone screw, 4x18mm; catalog#: 47248611840; lot#: 3006022.Cortical bone screw, 4x24mm; catalog#: 47248612440; lot#: 3024293.Cortical bone screw, 4x32mm; catalog#: 47248613240; lot#: 3024414.Cortical bone screw, 4x28mm; catalog#: 47248612840; lot#: 3024366.Blunt tip screw, 4x38mm; catalog#: 47248603840; lot#: 3010636.Blunt tip screw, 4x40mm; catalog#: 47248604040; lot#: 3024686.Blunt tip screw, 4x42mm; catalog#: 47248604240; lot#: 3010650.Proximal humerus nail cap, 10.5x7.5mm; catalog#: 47248801007; lot#: 3010712.Humerus calibrated drill, 3.3mm, sterile; catalog#: 110035651; lot#: 3018235.Humerus ball nose guidewire, sterile; catalog#: 110035668; lot#: 3038409.Proximal humerus pin coring, 2.5x280mm, 11.0mm; catalog#: 110035664; lot#: unknown.Therapy date: unknown.The manufacturer received other source of documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
Event or Problem Description
Patient was implanted with medial distal screws on an unknown side and experienced nerve injury.Hence an in out screw was discarded post the surgery.Remaining screws were not removed.Nerve repair was done on (b)(6) 2021.
Additional Manufacturer Narrative
Event description: it was reported that the patient was implants with an affixus nail on (b)(6) 2021.The cortical screw was an in/out screw and discarded.As the patient experiences some weekness, a nerve damage was suspected and the patient was reoperated on (b)(6) 2021.There was some bruising on the radial nerve, but no nerve repair needed to be performed.Review of received data: no medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implants with an affixus nail on (b)(6) 2021.The cortical screw was an in/out screw and discarded.As the patient experiences some weekness, a nerve damage was suspected and the patient was reoperated on (b)(6) 2021.There was some bruising on the radial nerve, but no nerve repair needed to be performed.Based on the investigation the reported event cannot be confirmed.Neither the explanted screw nor a surgical report was received.It remains unknown, whether an uninteded surgical error might have caused or contributed to the nerve damage.Further factors which might have caused or contributed to the nerve damage remain unknown.The packaging insert of the affixus humeral nail list as a possible adverse event (nerve damage).The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation has been completed and the event has been updated.Event clarification received they had to re operate the patient as they thought there was some nerve damage as the patient was facing some weakness.However upon exploring the surgical site where the distal screws were inserted.They observed that there was some bruising on the radial nerve and no nerve repair was needed to be done to the patient.

• Brand Name: CORTICAL BONE SCREW, 4X22MM
• Common Device Name: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11201699
• Report Number: 0009613350-2021-00027
• Device Sequence Number: 2270255
• Product Code: HSB
• UDI-Device Identifier: 00889024505315
• UDI-Public: 00889024505315
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-122-40
• Device Lot Number: 3024278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention