MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED FLEXIBLE DEPTH GAGE E; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Item number :00771101210, item name: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset reduced neck length, lot #: 64632166.Item number: 00625006520, item name: bone screw self-tapping6.5 mm dia.20 mm length, lot # : 64690841.Item number: 00877503201, item name: biolox⮠delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14, lot #: 3005283.Item number: 00875304801, item name: shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners, lot #: 64527624.Item number: 00625006520 ,item name bone screw self-tapping6.5 mm dia.20 mm length, lot #: 64690841.Item number: 00877500832, item name: biolox⮠delta ceramic taper liner, size gg / 32 i.D.For use with 48 mm o.D.Size gg shell, lot #: 3041407.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Previously incorrectly reported under mfr 0009613350 -2021 - 00421.
Event or Problem Description
It is reported that during the operation, in the process of screw insertion, the resistance was found to be large.The screw channel was checked and the head end of the depth gauge was found missing.Then the drilling channel was checked and no depth gauge with fractured tip was found.Intraoperative x-ray fluoroscopy was conducted and the fractured tip was found inside the patient.An 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.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a2; a3; a4; a5; b7;d9; g3; h2; h4 corrected: d4 lot number product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h6.  a calibrated flexible depth gauge was returned and evaluated.The measurement stem of the device had fractured.The device has 8 years of field service age and it is unknown how many times the device was used.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified fractured metal object within the left pelvis, likely representing the fractured tip described in the patient's history.A definitive root cause could not 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: CALIBRATED FLEXIBLE DEPTH GAGE E
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12436499
• Report Number: 0001825034-2021-02614
• Device Sequence Number: 4056759
• Product Code: HXC
• UDI-Device Identifier: 00889024303270
• UDI-Public: 00889024303270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 424492
• Device Lot Number: 328660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 01/12/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/04/2021; 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: Asian