MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH POSITIONING GUIDE, LATERAL, 20°; MAXERA INSTRUMENTS

Model Number N/A

Device Problem Material Integrity Problem (2978)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

Upon inserting the cup, surgeon connected the alignment guide onto the cup holder.While impacting the cup holder, the screw on the alignment guide broke and fell into the wound.Surgeon managed to remove the screw from the wound, however, the black rubber bump that came with the screw was unable to find.

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.It was reported that while impacting the cup, the screw on the positioning guide broke and fell into the wound.The screw could be removed, however, the black rubber bump could not be found.The visual examination of the returned device confirms that the m4 screw is broken.The fracture is right next to the knob and the black o-ring is missing.No deviations and/or anomalies were discovered during manufacturing that may have affected the surgical outcome or contributed to the reported event.Therefore, it is not expected that the manufacturing process contributed to the reported issue.Device is used for treatment.The o-ring is a necessary component to ensure the mechanical function of the lateral positioning guide.The investigation did not identify a definite cause for the screw breakage that led to the disassembly of the o-ring.The reported event can be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: POSITIONING GUIDE, LATERAL, 20°
• Type of Device: MAXERA INSTRUMENTS
• 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: 13557082
• MDR Text Key: 288589988
• Report Number: 0009613350-2022-00097
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024283220
• UDI-Public: (01)00889024283220(10)4503402759
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: N/A
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00639.725
• Device Lot Number: 4503402759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization