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

Catalog Number UNK DRILL

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Limb Fracture (4518)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: the device associated with this report was not returned for evaluation, no confirmation of failure could occur.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

I have been advised that consultant surgeon, mr.(b)(6), had an issue seating a size 12 corail 12/14 amt collared stem implant, during a primary total hip replacement yesterday, (b)(6) 2021 at (b)(6) hospital.Following broaching with a size 12 broach and trialing satisfactorily, the definitive size 12 stem sat 3 cm proud from the calcar to the underside of the collar.K-wires were used to retrieve the stem as an extractor instrument was unavailable and surgery delayed by 2.5 hours.A c-stem amt 12/14 stem was implanted instead, once the corail was removed.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary the device associated with this report was not returned for evaluation, no confirmation of failure could occur.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a manufacturing record 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: 12584042
• MDR Text Key: 274972966
• Report Number: 1818910-2021-22163
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK DRILL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 11/03/2021; 11/30/2021; 02/15/2022
• Supplement Dates FDA Received: 11/10/2021; 12/01/2021; 02/16/2022
• 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: ALTRX NEUT 36IDX52OD; CORAIL AMT COLLAR SIZE 12; PINNACLE SECTOR II CUP 52MM; ALTRX NEUT 36IDX52OD; CORAIL AMT COLLAR SIZE 12; PINNACLE SECTOR II CUP 52MM
• Patient Age: 83 YR