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

Model Number 03.100.018

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

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 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 (b)(6) 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.This is report 3 of 15 for complaint (b)(4).

• Brand Name: STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11863312
• MDR Text Key: 280522989
• Report Number: 8030965-2021-04121
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10886982070678
• UDI-Public: (01)10886982070678
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 03.100.018
• Device Catalogue Number: 03.100.018
• Device Lot Number: T180075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALL SPIK STRAIG LONG 6.5 L400; BEND-IRON F/LCP PILON-PL 2.7/3.5 L190; CABLE PASSER LRG; CABLE PASSER LRG 45° ANGLE; CABLE PASSER LRG CURV; CABLE PASSER MED; CABLE PASSER MED 45° ANGLE; CUTT-PLIERS W/POSITION-PIN Ø3; HAND F/TORQUE LIMITER NOS. 511.770+511.7; HANDLE W/QUICK-COUPL; PERIOST-ELEV SLIGHTLY CURV-BLADE ROUND E; RATCHET-HANDLE W/AO/ASIF-QC; SCRDRIVER-HEX ÿ2.5 W/GROOVE; SCRDRIVER-HEX-SMALL Ø2.5 L270; UNKNOWN SYN PRODUCT