MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

Event Type  malfunction  

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

Delta extend reverse shoulder arthroplasty procedure.During the procedure the surgeon could not get the glenosphere to seat properly.While attempting to remove the glenosphere, the surgeon felt that the two locking metaglene screws were not seated properly.He attempted to remove them to better seat them, but had difficulty with one of them, so it was left in place.A second screw was replaced with a shorter screw and it seated to the surgeon¿s satisfaction.The surgeon then chiseled away a small piece of bone inferior to the metaglene in order to further reduce potential for impingement.Before the surgeon tried again i inspected the removed glenosphere and noticed the threads were damaged.I recommended replacing it with a new one, which we fortunately had as backup.The new glenosphere seated immediately and seemed to be well fixed, with the correct technique applied to tighten it down.Surgical delay of 20 minutes occurred.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received stated: some elaboration: this was a very tight exposure and the surgeon had some difficulty in ensuring alignment of the glenosphere screw on the axis of the metaglene; his retractors seemed to be pushing the glenosphere out of alignment.Although he routinely inserts the glenosphere over a guide wire, in this instance the wire became bent and unhelpful.He persevered in trying to screw down the glenosphere, and squeaking noises were heard, though the glenosphere failed to seat.After removing the first glenosphere he removed a small piece of bone from the anterior-inferior glenoid rim, though he felt it was not significant.Upon replacement of the glenosphere with a new one, he removed the retractor that was pushing the glenosphere out of alignment and took additional care to ensure axial alignment before tightening.The second attempt was successful.The surgeon had the perception that the screws seemed a little proud, but this cannot be validated.He and i have since discussed the issue further, prior to his next case, and concluded that he had drilled both superior and inferior holes together (to save time).This may have caused the second screw to seem tighter due to sub-optimal alignment, but impossible to say for certain.The second screw was not too long according to depth gauge measurement, but he elected to put a shorter screw to see if it would seat better.The damage to the threads on the glenosphere were not caused by the metaglene screws.There were no adverse consequences.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.No images that depict this specific product were attached.It is not possible to identify or confirm a product malfunction.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a worldwide lot specific complaint database search, or manufacturing record evaluation was not possible, as the required part/lot number was not provided.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: UNK SHOULDER LOCKING SCREW
• 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: 13539300
• MDR Text Key: 285700765
• Report Number: 1818910-2022-02899
• Device Sequence Number: 1
• Product Code: PHX
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• 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: DXTEND GLENOSPHERE STD D38MM; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE