MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN BATTERY POWERED HANDPIECES; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number UNK-BATTERY-POWERED-HANDPIECES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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.Catalog number, serial number and lot number are unknown.The device serial or lot number was unknown; therefore, udi: unknown.510(k) number is unknown.The manufacturing site name and address are unknown.Device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

The literature article entitled, "pulsed electromagnetic field therapy improves osseous consolidation after high tibial osteotomy in elderly patients¿a randomized, placebo-controlled, double-blind trial" written by patrick ziegler, andreas k.Nussler, benjamin wilbrand, karsten falldorf, fabian springer, anne-kristin fentz, georg eschenburg, andreas ziegler, ulrich stockle, elke maurer, atesch ateschrang, steffen schroter and sabrina ehnert.The article's purpose was to study how extremely low-frequency pulsed electromagnetic field (elf-pemf) therapy is proposed to support bone healing after injuries and surgical procedures, being of special interest for elderly patients.The study aimed at investigating the effect of specific elf-pemf, recently identified to support osteoblast function in vitro, on bone healing after high tibial osteotomy (hto).The article reported that two unknown patients (one from each group) w/an unknown depuy synthes battery powered handpiece device, experienced post operative infections requiring additional intervention.Depuy product involved: unknown battery power handpiece (trs) device.Adverse event: post operative infection requiring additional intervention.

• Brand Name: UNKNOWN BATTERY POWERED HANDPIECES
• 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: 14601173
• MDR Text Key: 293341393
• Report Number: 8030965-2022-03333
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BATTERY-POWERED-HANDPIECES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention