MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DRILL; DRILLS

Catalog Number UNK DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Perforation of Vessels (2135); Thromboembolism (2654); Unspecified Tissue Injury (4559)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: ayob ka, merican am, sulaiman sh, hariz ramli ar.The tale of two vessels, vascular complications following a breach of the pelvic inner table due to acetabular screws: a report of two cases.Jt dis relat surg.2021;32(1):239-244.Doi: 10.5606/ehc.2021.77862.Pmid: 33463444; pmcid: pmc8073450.Objective and methods: the purpose of this article, the authors report two cases from their surgical center occurring within a six-month interval that sustained a vascular injury during acetabular drilling for screw placement for cementless cup fixation.The first case had an injury of the inferior gluteal artery following a breach of the sciatic notch.The vessel was treated with percutaneous embolization.The second case demonstrated a venous injury, following a medial protrusio technique for congenital hip dysplasia and a short anterosuperior screw, transecting the external iliac vein.This was subsequently repaired using an endovascular technique.The first case occurred utilizing competitor products.This complaint will capture case2, which utilized depuy products.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: unknown pinnacle drill adverse event(s) and provided interventions associated with depuy devices: case 2: (b)(6) year-old female patient received a left s/rom pinnacle tha to treat neglected ddh crowe type 4 with high-riding dislocated natural femoral head.Due to the patient¿s poor acetabular bone stock, the surgeons elected to perform a medial protrusion technique to allow for better purchase of the acetabular cup.While drilling a screw hole in the superior aspect of the acetabulum, the surgeon noted there was a gush of blood through the screw hole.The bleeding ceased and the patient remained hemodynamically stable, and the surgeon inserted the screw and completed the surgery without further incident.After the surgery, the patient experienced progressive swelling of the operative limb.At 48 hours, the swelling was 5 cm greater than the contralateral side.A doppler ultrasound confirmed a long segment thrombosis starting at the left popliteal vein, extending to the left external iliac vein.A ct venogram confirmed a hematoma deep to the acetabular cup.The external iliac vein (eiv) was non-opacified while its tributaries, the common femoral vein and the superficial femoral vein were dilated with hypodensity, likely from developing a thrombus caused by the drilling of the screw hole.The thromboembolism was repaired surgically with a ivc filter and a 10x80 vascular graft stent.The eiv was successfully recanalized without revision of any tha devices.The patient made a full recovery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The photographs provided within the journal article doesn't show enough evidence to confirm the reported allegation.Nothing indicative of a product problem is identified.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK DRILL
• Type of Device: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12666334
• MDR Text Key: 277453821
• Report Number: 1818910-2021-23068
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRILL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL SLEEVE SROM; UNK HIP FEMORAL STEM SROM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL SLEEVE SROM; UNK HIP FEMORAL STEM SROM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Asian