MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG SONICWELD RX; SONICPIN

Model Number	52-621-24-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Product lot numbers: 33257038, 33257038, 33261985, 33240736.
Event or Problem Description
It was reported the pins were removed due to patient condition.
Additional Manufacturer Narrative
Related: mdr 9610905-2019-00137, mdr 9610905-2019-00138.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed and the returned parts were tested and revealed that the viscosity was according to the specification.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause is patient related as no device issue was found.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Manufacturing date: 33257038 2018-06-20, 33261985 2018-07-25, 33240736 2018-03-12.

• Brand Name: SONICWELD RX
• Common Device Name: SONICPIN
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8750202
• Report Number: 9610905-2019-00136
• Device Sequence Number: 13934624
• Product Code: JEY
• UDI-Device Identifier: 10888118001273
• UDI-Public: (01)10888118001273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2019
• Report Date (Section F): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 52-621-24-04
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 11/15/2019; 05/04/2020
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/02/2019; 12/13/2019; 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 MO
• Patient Weight: 11