MAUDE Adverse Event Report: SYNTHES GMBH BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.715

Device Problems Physical Resistance/Sticking (4012); Complete Loss of Power (4015)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: udi: (b)(4).The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.Investigation summary - "service evaluation: product: 530.715 (battery reciprocator ii for bpl ii)/ 101017.Reported issue: does not work.A visual and functional assessment was performed on the device according to se_473934_ai.The following steps failed: section 10: general condition.Section 70: check for sticky trigger.Section 80: check function of device.Section 110: check oscillation frequency with frequency meter (record, 5 digits, the value of frequency meter).During service/repair the following was observed (technician note): pre-internal comment: ng, reproduced, terminal corrosion dirty, trigger stuck, not working.During the service evaluation the following failures were identified: visual : contact damage.Functional : moving parts do not move smoothly - trigger.Functional : will not run.Conclusion: ¿ failure reported is confirmed.¿ root cause: faulty parts (3210).¿ action: repair".Device history lot - null.Device history batch - null.Device history review - no manufacturing record evaluation required as no manufacturer or service related issue found.

Event Description

It was reported from japan that during service and evaluation, it was determined that the battery reciprocator device had the following failures: contact damage, moving parts do not move smoothly - trigger and will not run.It was further determined that the device failed pretest on general condition, check for sticky trigger, check function of device and check oscillation frequency with frequency meter.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 unknown but was noted to have occurred in 2023.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.

• Brand Name: BATTERY RECIPROCATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 19105458
• MDR Text Key: 340909852
• Report Number: 8030965-2024-05096
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491854
• UDI-Public: 07611819491854
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1