MAUDE Adverse Event Report: DEPUY SPINE INC PIPELINE LS DILATOR HOLDER; MISC ORTHO SURGICAL INSTR

Model Number	287105015
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Event date is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Investigation summary: investigation flow: visual/damage.Visual inspection: the pipeline ls dilator holder (part # 287105015/ lot # kw1743585) was received at us cq.A small portion of the nylon coating was broken off one of the jaws of the dilator.The broken nylon coat piece was missing and not returned to us cq.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes.A small portion of the nylon coat broken off.Dimensional inspection: the dimensional inspection cannot be performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the overall complaint was confirmed for the received the pipeline ls dilator holder as the nylon coating has broken off.The alleged missing component was occurred due to the missing broken nylon coat piece.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot: a review of the receiving inspection (ri) for pipeline ls dilator holder was conducted identifying that lot number kw1743585 was released in a single batch.Batch1: lot qty of (b)(4) units were released on jan 10, 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during the sterilization process, it was noticed that the rubber insulation of the clamp is no longer complete.There was a piece is missing.It was not clear whether the piece of rubber fell off during the surgery.It was unknown if the surgery completed successfully.There were no patient consequences.This complaint involves one (1) device.This report is for (1) pipeline ls dilator holder.This report is 1 of 1 (b)(4).

• Brand Name: PIPELINE LS DILATOR HOLDER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11773536
• Report Number: 1526439-2021-00885
• Device Sequence Number: 4137812
• Product Code: LXH
• UDI-Device Identifier: 10705034217604
• UDI-Public: 10705034217604
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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 Model Number: 287105015
• Device Catalogue Number: 287105015
• Device Lot Number: KW1743585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1