MAUDE Adverse Event Report: SYNTHES GMBH 3.5 TI LCP PROX HUM PL-STD 5H SFT/114; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number	441.903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: yu, rf.Et al., (2019), a comparison of the new bone cement reinforced screw with lock sheet steel fixation and artificial humerus replacement for proximal osteoporosis fracture treatment of humerus, chinese journal of tissue engineering research, vol.15 (xx) pages 2335-2339.(china).The aim of this retrospective case analyses was to compare the clinical efficacy of the new bone cement screw technology combined with fixed in locked steel plate and artificial humerus bone replacement in the treatment of a proximal osteoporotic fracture of the humerus.Between february 2017 to march 2019, a total of 22 patients with osteoporotic fractures of the proximal were included in the study, including 8 males and 14 females, aged 68-88 years.10 patients underwent open reduction using new cement-reinforced screws combined with locking plate internal fixation (internal fixation group), and 12 patients underwent humeral head arthroplasty (humeral head arthroplasy group).This study was treated with bone cement reinforced screw technology using cut-open reset hollow locking screw combined with the brachial proximal locking steel plate fixing using depuy synthes philos humerus proximal bone plate and depuy synthes traumatic bone cement for the internal fixation group and non-depuy synthes device for the brachial bone replacement group.The two groups were compared for surgical time, intraoperative bleeding volume, intraoperative and postoperative complications; shoulder-examination program scores and shoulder constant scores were performed 6 months after surgery.All patients were treated with antiosteoporosis after the procedure.The median clinical follow-up was 9.0 ± 1.6 months.The following complications were reported as follows: internal fixation group: - one case of postoperative shoulder stiffness.This report is for philos humerus proximal bone plate (depuy synthes).This is report 1 of 2 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: part# 441.903; lot# l624242; manufacturing site: werk raron chba; release to warehouse date: 17 nov 2017; supplier: n/a; expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 3.5 TI LCP PROX HUM PL-STD 5H SFT/114
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16787505
• Report Number: 8030965-2023-05079
• Device Sequence Number: 5554161
• Product Code: KTW
• UDI-Device Identifier: 10886982222466
• UDI-Public: 10886982222466
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 441.903
• Device Catalogue Number: 441.903
• Device Lot Number: L624242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown