MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 METAGLENE HOLDER INTERNAL ROD; EXTREMITY INSTRUMENTS : HANDLES

Catalog Number	230787002
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this is not a complaint about the function of an instrument or in any way a concern over patient safety.Just need a replacement and doing this because it¿s required.Nurse did not tighten blue handle enough to secure metaglene via hex connection and implant was dropped.Surgeon over tightened blue handle while i was retrieving second implant.This caused over expansion of hex head and damaged the top of internal expander rod.Convex head impactor used to implant second metaglene.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that metaglene holder internal rod was found the threaded tip stripped.No other defect was found.The overall complaint was confirmed as the observed condition of the etaglene holder internal rod would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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 or Problem Description
It was reported that the nurse did not tighten blue handle enough to secure metaglene via hex connection and implant was dropped.Surgeon over tightened blue handle.This caused over expansion of hex head and damaged the top of internal expander rod.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 5 mins.Action taken when event occurred? second implant provided and impacted with convex impactor tip.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study unknown.(b)(4).Device property of none.Device in possession of hospital csd.(b)(4).Device property of none.Device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

• Brand Name: METAGLENE HOLDER INTERNAL ROD
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17754620
• Report Number: 1818910-2023-18832
• Device Sequence Number: 15206344
• Product Code: HWA
• UDI-Device Identifier: 10603295116431
• UDI-Public: 10603295116431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 230787002
• Device Lot Number: 5219830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown