MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK HANDLE

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the product is missing a bolt to hold it together and now does not attach to the broach part.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 Description

Sri instrument investigation report was provided: product coder: apau0200.Product name: daa, straight broach handle.Batch: enz010917.Investigation summary: the instrument was designed and developed according to the anz sri procedure (tv-sop-00911) and manufactured to specification with no deviations recorded.The instrument was first released in 2016.A total of 50 instruments have been manufactured with this product code, with the product code being available since 2016.The instrument was removed from circulation and segregated in locked returned instrument cupboard during the investigation period.Whereafter returned instruments will be scrapped per franchise complaint handling policy (b)(4) and anz product waste management (tv-sop-00982).The mechanical feature related to the complaint is equivalent to the comparator instrument: c1421901.Complaint review meeting on 5th august 2021 determined issue is related to wear and tear.A design specification was included of a weld to reinforce the interface between top hat and slide pin.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, it was reported that the product is missing a bolt to hold it together and now does not attach to the broach part.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.Product coder: apau0200.Product name: daa, straight broach handle.Batch: enz010917.The product was returned to depuy synthes sri team, additionally photos were provided for review.See attachment (2.Jpg, 1.Jpg).The physical evaluation determined that one pin was missing and without it, the correct assembly is not possible.The photo revealed that the device exhibits an overall worn appearance consistent with normal an repetitive usage.The potential cause can be related to end of life, wear, and tear from normal use (with impaction).The observed condition is consistent with use and service over the years.The overall complaint was confirmed as the observed condition of the daa, straight broach handle would contribute to the complained device issue.Based on the investigation findings, the potential cause traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18911699
• MDR Text Key: 337743253
• Report Number: 1818910-2024-05812
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/15/2024

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 Operator: Health Professional
• Device Catalogue Number: UNK HANDLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1