MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN INSERTION INSTRUMENTS; MISC ORTHO SURGICAL INSTR

Lot Number ENZ290616

Device Problem Material Integrity Problem (2978)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in australia as follows: it was reported that on an unknown date, the instrument was damaged.This report involves one (1) unknown insertion instrument.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this report is for an unknown insertion instruments/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Part # 2867-55-001n, lot # enz290616, manufacturing site: enztec, release to warehouse date: 29 jun 2016.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photos.Visual analysis of the photo revealed that the unk insertion instruments was found broken, the broken fragment is not visible in photos.No other problems were observed.In addition according to the australian investigation team: "the item was returned for inspection and the issue could be confirmed.Per the lot number recorded the instrument was first released in 2016.A total of 28 instruments have been manufactured with this product code, with the product code being available since 2015.6 similar (and 1 dissimilar) complaints are now identified against this product code.The mechanical feature related to the complaint is equivalent to the comparator instrument: 2867-55-001n.The complaints history of the comparator instrument was updated and is consistent with the failure mode.The sri design does not exacerbate the failure mode for this complaint.A review of the product was conducted.This review determined that design alteration was not preferable due to the low likelihood of patient risk and the potential introduction of new risks.This event does not indicate an increase in frequency of complaints.The product was designed and developed according to the apac sri procedure, and manufactured to specification with no deviations recorded.The product was removed from circulation and will be quarantined during the investigation period.Whereafter it will be available to be scrapped; per franchise complaint handling policy and anz product waste management as the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for unk insertion instruments.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN INSERTION INSTRUMENTS
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15683629
• MDR Text Key: 307027698
• Report Number: 1526439-2022-01879
• Device Sequence Number: 1
• Product Code: LXH
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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 Lot Number: ENZ290616
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/27/2022
• 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