MAUDE Adverse Event Report: DEPUY SPINE INC STANDARD RASP/TRIAL ASSY SZ 7; RASP, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 698273327

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Libertas: broken instrument.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).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.Investigation summary: background: (b)(6) 2019 updated event description: libertas: it was reported that on (b)(6) 2019, the standard rasp/trial assy sz 7 was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.Investigation flow: damage (broken) visual inspection: device failure/ defect found? yes dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: the following drawings were reviewed during the investigation: -modified standard rasp assy sizes 4 thru 16: dwg-698273324/29 rev.D no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.The device was observed to be broken.Thus, the complaint is confirmed.While a definitive root cause for the reported problem cannot be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 history: a review of the device history record (dhr) could not be performed as no manufacturing records could be found for this part # 698273327/ lot # g0202 combination.If further information becomes available, this dhr can be revisited.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STANDARD RASP/TRIAL ASSY SZ 7
• Type of Device: RASP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9174428
• MDR Text Key: 176841024
• Report Number: 1526439-2019-52230
• Device Sequence Number: 1
• Product Code: GAC
• UDI-Device Identifier: 10705034448350
• UDI-Public: 10705034448350
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 698273327
• Device Lot Number: G0202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1