MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X38MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Medical product: blunt tip screw, 4x46mm, catalog#: 47-2486-046-40; lot#: 3024720, cortical bone screw, 4x22mm, catalog#: 47-2486-122-40; lot#: 3076794, cortical bone screw, 4x24mm, catalog#: 47-2486-124-40; lot#: 3076810, proximal humerus nail cap, 0mm, catalog#: 47-2488-010-00 ; lot#: 3068908.X-rays received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00002; 0009613350-2022-00003; 0009613350-2022-00004.Remains implanted,.

Event Description

It was reported that operation was performed with nail on.After 1 week from the initial, surgeon found 1 screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.Patient outcome under observation.

Event Description

It was reported that operation was performed with nail on.After 1 week from the initial, surgeon found 1 screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.Patient outcome under observation.

Manufacturer Narrative

Medical product: blunt tip screw, 4x46mm, catalog#: 47-2486-046-40; lot#: 3024720, cortical bone screw, 4x22mm, catalog#: 47-2486-122-40; lot#: 3076794, cortical bone screw, 4x24mm, catalog#: 47-2486-124-40; lot#: 3076810, proximal humerus nail cap, 0mm, catalog#: 47-2488-010-00 ; lot#: 3068908.X-rays received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00002; 0009613350-2022-00003; 0009613350-2022-00004.Remains implanted,.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: a1, a2, a3, e1, h2, h6, h10.Event description: it was reported that one week after implantation, one of the proximal screws was backed out from the proper position.No revision is planned.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: the provided x-rays were reviewed by a health care professional.The review found that there is an intramedullary nail with proximal and distal screw fixation that traverses a humeral neck fracture.On the left image (dated (b)(6) 2021), the most proximal screw has backed out.The fracture alignment is maintained.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Surgical technique sap: identified that the interlocking screws should be locked using the corelock driver after the placement of all screws.It was noted that the surgeon followed the surgical technique.Conclusion: it was reported that one week after implantation, one of the proximal screws was backed out from the proper position.No revision is planned.Based on the investigation the reported event can be confirmed.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).

• Brand Name: BLUNT TIP SCREW, 4X38MM
• Type of Device: 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13142229
• MDR Text Key: 285612229
• Report Number: 0009613350-2022-00001
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505438
• UDI-Public: 00889024505438
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-038-40
• Device Lot Number: 3072440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Sex: Female