MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DEPTH GAUGE; HIP INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset reduced neck length; catalog#: 00-7711-012-10; lot#: 64632166 bone screw self-tapping 6.5 mm dia.20 mm length; catalog#: 00-6250-065-20; lot#: 64690841 biolox delta, ceramic femoral head, s, 32/-3.5, taper 12/14; catalog#: 00-8775-032-01; lot#: 3005283 shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners; catalog#: 00-8753-048-01; lot#: 64527624 bone screw self-tapping 6.5 mm dia.20 mm length; catalog#: 00-6250-065-20; lot#: 64690841 biolox delta ceramic taper liner, size gg / 32 i.D.For use with 48 mm o.D.Size gg shell; catalog#: 00-8775-008-32; lot#: 3041407.Therapy date: unknown.The manufacturer received x-ray and other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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).

Event Description

During a surgery while implanting the acetabular cup, a large resistance was encountered while inserting the screw.The screw channel was checked and it was reported that the head end of the depth gauge was missing.Intra-operative x-ray fluoroscopy was conducted and the fractured tip was found inside the patient.Immediate attempt was made to remove the fractured tip.The surgeon had to expand the scope and an additional opening had to be done due to the deep positioning of the fractured tip.Complete anastomosis of the fractured tip was confirmed on the operating table.The surgery was completed after removing the fractured tip.There was a surgical delay of 2 hours.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be reported on wrong and will be reported on mfr number 0001825034 - 2021 - 02614.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be reported on wrong and will be reported on mfr number 0001825034 - 2021 - 02614.

• Brand Name: DEPTH GAUGE
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12353504
• MDR Text Key: 267823015
• Report Number: 0009613350-2021-00421
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization