MAUDE Adverse Event Report: SYNTHES GMBH SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	532.103
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.The battery device was evaluated and the reported condition that the device did not work was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was leaking liquid and had component damage.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the battery device for the small battery drive device was leaking liquid and had component damage.It was noted in the service order that the device did not work.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.The battery device was evaluated and the reported condition that the device did not work was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was leaking liquid and had component damage.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the battery device for the small battery drive device was leaking liquid and had component damage.It was noted in the service order that the device did not work.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13417258
• Report Number: 8030965-2022-00624
• Device Sequence Number: 4826519
• Product Code: HWE
• UDI-Device Identifier: 07611819408333
• UDI-Public: 07611819408333
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 532.103
• Device Lot Number: 150818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown