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

Catalog Number 03.100.019

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2021 during an unknown procedure, the straight ball spike broke.The metal top disconnected from the handle and a pin was missing.X-ray was performed to confirm that the pin was not left in the patient.There was no patient consequence.The procedure was successfully completed with an unknown amount of surgical delay.This report is for one (1) straight ball spike for low profile pelvic system-long.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.H3, h6: part number: 03.100.019, lot number: a7qa25, manufacturing site: tuttlingen, release to warehouse date: week 25, 2007.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 13 years old).Investigation flow: visual.Visual inspection: the ball spik straig long 6.5 l400 (p/n: 03.100.019, lot number: a7qa25) was received at us customer quality (cq).Visual inspection of the complaint device showed two pins were missing - one holding the cap on, and one near the distal end of the handpiece.No components were observed broken.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as two pins were missing - one holding the cap on, and one near the distal end of the handpiece.No components were observed broken.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.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.

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.H10 additional narrative: d4: lot.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11712383
• MDR Text Key: 247248004
• Report Number: 8030965-2021-03178
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 07611819796638
• UDI-Public: (01)07611819796638
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.100.019
• Device Lot Number: A7QA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIKED DISC ROUND-HO 6.5.