MAUDE Adverse Event Report: SYNTHES GMBH STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG; RETRACTOR

Catalog Number	03.100.019
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that, the non-acceptance of the instrument with cable in celeron material by the unimed hospital materials center, we consulted with nurse (b)(6), responsible for the technical area of the hospital's materials center.It is a material that has porosity due to exposure to the temperature of the sterilization process.It is the porosity of the celeron that compromises the cleaning process.It was understood then that the material compromises the sterilization process, since it has porosity that does not guarantee the effectiveness of cleaning.If you are not in accordance with the justification presented, i suggest that you present to the hospital technicians responsible, a document with the manufacturer's specifications that meet the standards of the manuals of good cleaning and sterilization practices.This report is for one (1) straight ball spike for low profile pelvic system-long.This is report 12 of 15 for complaint (b)(4).

• Brand Name: STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11866450
• Report Number: 8030965-2021-04149
• Device Sequence Number: 14383904
• Product Code: GAD
• UDI-Device Identifier: 07611819796638
• UDI-Public: (01)07611819796638
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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 Catalogue Number: 03.100.019
• Device Lot Number: T180868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1